Get a quote
Direct Medical Manufacturer · Est. 2008

Direct Manufacturer of Patient Monitoring Cables & Medical Sensors

Delivering ISO 13485:2016 audited, EU MDR CE certified, and US FDA 510(k) cleared patient monitoring accessories. Providing healthcare facilities and global distributors with 100% plug-and-play signal precision, biological safety, and OEM engineering agility.

TÜV SÜD ISO 13485:2016 & MDR CE
US FDA FEI 3012804266 & 510(k) Cleared
100% Electrical & Hipot Safety Testing
Fast OEM/ODM Prototyping (7-15 Days)
Get Factory Pricing & SamplesVerify Regulatory Records →
Direct Factory Assurance: Biocompatible medical TPU · 100% signal matched pinouts · Free evaluation samples
Medke Headquarters & Manufacturing Center
Bao'an, Shenzhen Plant
TÜV SÜD Audited QMS
Active & Valid
ISO 13485:2016 (Q5 085432 0005) & EU MDR CE (G15 085432 0008) · Class 100,000 Cleanroom
Medke Headquarters & Manufacturing Center
4,000㎡ ISO 13485 Audited Facility · Class 100,000 Cleanroom
Audited Plant
China NMPA
EU MDR
TÜV SÜD CE 0123
US FDA 510(k)
ISO 13485:2016
Saudi SFDA
Russia RZN
MDSAP Global
18+
Years of Manufacturing
Founded in 2008 in Shenzhen
4,000㎡
Factory & Cleanroom
Class 100,000 controlled zone
100+
Export Destinations
EU, Americas, APAC & GCC
90%+
Monitor Compatibility
Direct plug-and-play pinouts
350+
OEM/ODM Custom Projects
Tooling, private labeling & DHF
DIRECT PINOUT COMPATIBILITY|100% Plug-and-Play Precision for 90%+ Hospital Patient Monitors Worldwide
Philips Medical
Philips Medical
IntelliVue MX / MP · SureSigns
8-Pin / 12-Pin Plug & Play
GE Healthcare
Carescape B450/B650/B850 · Dash
11-Pin Multi-Link · TruSignal
Mindray
Mindray
BeneVision N-Series · ePM · uMEC
6-Pin / 7-Pin Validated
Dräger Medical
Dräger Medical
Infinity Delta, Vista · MultiMed
Pod Cable · Direct 7-Pin
Nihon Kohden
Life Scope BSM-2300/3000/6000
14-Pin Multi-Parameter
Masimo SET®
Radical-7, Rad-97 · Rainbow
LNCS / RD SET / M-LNCS
Nellcor™ OxiMax™
N-600x, PM1000N, N-560 Series
9-Pin / 14-Pin Resistor Code
Biolight
Biolight
AnyView A3/A5/A8 · Q-Series
Digital SpO2 · 5-Lead ECG
Edan Instruments
Edan Instruments
iM3, iM8, iM50 · Elite Series
100% Direct Plug Compatible
Comen Medical
Comen Medical
C50, C80, Star8000 · NC Series
Custom Molded Connectors
Schiller AG
Schiller AG
ARGUS, CARDIOVIT · DEFIGARD
DIN · Banana Electrode Cables
Bionet
Bionet
BM3, BM5 · BM7 Series
Locking 7-Pin Sensor Interface
Clinical Grade Solutions

8 Comprehensive Product Lines for Patient Care

Precision-engineered medical cables, transducers, and disposable consumables built in full compliance with ISO 10993 biological evaluation and IEC 60601-1 electrical safety standards.

FDA 510(k) · MDR CESpO2 Sensors & Cables

SpO2 Sensors & Cables

Reusable finger clips, soft silicone tips, wrap sensors, and disposable adhesive sensors. High accuracy even under low perfusion conditions.

Class IIb & Class IK152390 Cleared
Explore Series & Catalog →
Defibrillation-ProofECG Trunk Cables & Leads

ECG Trunk Cables & Leads

3-lead, 5-lead, and 12-lead trunk cables and telemetry leadwires with TPU low-noise dual shielding and built-in anti-defibrillation protection.

MDR Class I DoCAHA / IEC Colors
Explore Series & Catalog →
FDA 510(k) ClearedNIBP Cuffs & Air Tubes

NIBP Cuffs & Air Tubes

Reusable nylon cuffs and disposable non-woven cuffs from neonate to thigh sizes. Biocompatible TPU bladders and quick-connect fittings.

510(k) K242623Single/Dual Tube
Explore Series & Catalog →
Critical Care ICUIBP Cables & Transducers

IBP Cables & Transducers

Invasive arterial pressure adapter cables compatible with BD, Utah, Edwards, Abbott, Argon, and PVB transducer systems.

MDR-IBP-CE-0210+ Transducer Pinouts
Explore Series & Catalog →
YSI 400 / 700 SeriesTemperature Probes

Temperature Probes

Adult and pediatric skin surface probes, rectal/esophageal probes, and autoclavable general-purpose sensors with ±0.1°C clinical precision.

EU MDR Class IIbYSI 400 & 700 Compatible
Explore Series & Catalog →
ElectrosurgicalESU Pencils & Grounding Pads

ESU Pencils & Grounding Pads

Monopolar electrocautery pencils, split grounding plates (REM/CQM), and bipolar coagulating forceps cables engineered for operating rooms.

HF Surgical GradeValleylab / ConMed Fit
Explore Series & Catalog →
Emergency RescueAED Defibrillator Pads

AED Defibrillator Pads

Pre-gelled multi-function defibrillation electrode pads for public access AEDs and hospital resuscitation monitors.

Adult / PediatricPhilips, Zoll, Physio-Control
Explore Series & Catalog →
Neurology MonitoringEEG Electrodes & Leads

EEG Electrodes & Leads

Gold-plated cup electrodes, Ag/AgCl disposable sensors, and neurology leadwires for sleep labs and intraoperative neuromonitoring (IONM).

Low Impedance SignalDIN 42802 Standard
Explore Series & Catalog →
OEM Compatibility & Global Trust

Trusted for OEM Compatibility by Global Leaders

Our cables and sensors undergo rigorous benchtop signal testing to match or exceed the performance parameters of industry benchmark systems.

Philips Healthcare Logo
Mindray Medical Logo
Dräger Medical Logo
Edan Instruments Logo
Biolight Logo
Comen Medical Logo
Schiller AG Logo
Bionet Logo
Huntleigh Healthcare Logo
Withings / Nokia Health Logo
Audited & Validated Authority

International Medical Regulatory Authorizations

Medke operates under continuous notified body oversight and maintains active medical device market registrations across Europe, North America, the Middle East, and Eurasia.

QMS StandardActive

ISO 13485:2016

TÜV SÜD Product Service GmbH (NB 0123)
Certificate No.:Q5 085432 0005 Rev. 05
Validity Period:2026-01-17 ~ 2029-01-16
Audited Scope:SpO2, ECG, IBP, Temp Probes
View Certificate →
European UnionActive

EU MDR Class IIb CE

TÜV SÜD (NB 0123) · Annex IX Chapter I
Certificate No.:G15 085432 0008 Rev. 00
Validity Period:2026-03-23 ~ 2031-03-22
Manufacturer SRN:CN-MF-000019638
View CE Dossier →
United StatesActive

US FDA Premarket

U.S. Food and Drug Administration (FDA)
Facility FEI:3012804266
SpO2 Clearance:510(k) K152390 (DQA)
NIBP Clearance:510(k) K242623 (DXQ)
View 510(k) Records →
Saudi Arabia / GCCActive

Saudi SFDA Approval

Saudi Food and Drug Authority (SFDA)
Authorization:MDMA-2-2026-1892
Market Access:Kingdom of Saudi Arabia & GCC
Device Class:Class II Medical Accessories
View SFDA Permit →
Eurasian Union / RussiaActive

Russia RZN Registration

Roszdravnadzor (Federal Healthcare Service)
Registration No.:FSZ 2012/12398
Authorized Products:Patient Monitoring Cables & Sensors
GOST-R Status:Conformity Validated
View RZN Dossier →

Need Official Certificates for Hospital Tender Submission?

We provide watermarked original PDF certificates, Declarations of Conformity, and ISO 10993 test reports.

Request Compliance Dossier →
Industrial Manufacturing Rigor

4,000㎡ Modern Production & Testing Facility

Equipped with Class 100,000 controlled cleanrooms, automated high-precision wire extrusion, ultrasonic welding, and in-house biological and physical stress laboratories.

Interactive Factory Virtual Tour

Take an Inside Look at Medke's Cleanroom & Automated Assembly

Tour our 4,000㎡ manufacturing operations from raw TPU wire extrusion and Class 100,000 sensor encapsulation to robotic laser soldering and 100% dielectric Hipot screening.

Explore 3D VR Showroom →
Class 100,000 Cleanroom

Class 100,000 Cleanroom

Enclosed positive-pressure environment for clean sensor assembly and packaging.

Automated Assembly Lines

Automated Assembly Lines

Automated stripping, robotic soldering, and high-frequency molding ensuring batch consistency.

Reliability & Safety Lab

Reliability & Safety Lab

In-house bending fatigue, tensile pull, dielectric breakdown, and sterilization validation.

Barcoded Warehouse

Barcoded Warehouse

Constant temperature and humidity storage with lot-level ERP traceability for every dispatch.

100% Electrical & Hipot Testing

Every single cable is 100% verified for conductor continuity, pinout configuration, insulation resistance (>100MΩ), and 3000V AC dielectric withstand before packing.

ISO 10993 Biocompatibility

Medical-grade TPU and silicone raw materials are verified by third-party testing for cytotoxicity, skin irritation, and sensitization to protect sensitive patient skin.

100,000+ Flex Bending Durability

Strain reliefs and Kevlar-reinforced jacket designs undergo multi-angle mechanical flex testing to survive heavy-duty clinical handling in fast-paced ICU environments.

Custom Medical Engineering

5-Stage Structured OEM/ODM Development Cycle

From proprietary monitor connectors to specialized veterinary sensor geometries, Medke delivers turn-key technical execution backed by rigorous DHF documentation.

01

Requirements & Pinout Analysis

NDA execution, clinical application scope review, connector geometry validation, and electrical impedance tolerance definition.

Phase 1 · Day 1-3
02

Tooling & Mold Engineering

3D CAD modeling, DFM simulation, in-house precision EDM mold manufacturing, and silicone/TPU material batch compounding.

Phase 2 · Day 4-10
03

Prototyping & Lab Validation

Rapid working sample build, optical wavelength calibration for SpO2, signal-to-noise ratio bench test, and customer sign-off.

Phase 3 · Day 11-15
04

Mass Production & 100% QC

ERP lot-controlled cleanroom assembly, automated crimping, laser engraving, serial number tracking, and 100% dielectric Hipot screening.

Phase 4 · Pilot to Batch
05

Regulatory Dossier Support

Delivery of complete technical documentation (ISO 10993, RoHS, biocompatibility reports) to accelerate your local MDR/FDA registration.

Phase 5 · Full Compliance
Point-of-Care Reliability

Engineered for Critical Hospital Departments

Medke cables and sensors operate under the most demanding clinical environments where signal integrity directly safeguards patient lives.

Intensive Care Units (ICU / CCU)

Intensive Care Units (ICU / CCU)

Continuous multi-parameter monitoring cables designed for low drift, high biological safety, and non-stop 24/7 telemetry stability.

Continuous SpO2 • IBP • ECG
Operating Rooms (OR)

Operating Rooms (OR)

High-frequency anti-electrosurgery shielding prevents monitor display interference during active electrocautery cutting and coagulation.

ESU Grounding • Temperature Probes
Emergency & Resuscitation

Emergency & Resuscitation

Ruggedized AED defibrillator pads and impact-resistant trunk cables optimized for rapid deployment in mobile paramedic ambulances.

AED Pads • Portable NIBP Cuffs
General Wards & Neonatology

General Wards & Neonatology

Cost-effective disposable non-woven cuffs and gentle silicone soft sensors specifically sized to protect delicate premature neonatal skin.

Neonatal Wrap SpO2 • Soft Cuffs
Verified Client Reviews

What Medical Device Buyers Say About Medke

Trusted by hospital biomedical engineers, procurement directors, and tier-1 medical distributors across Europe, the Americas, Middle East, and Asia.

★★★★★

"We have procured Medke SpO2 sensors and ECG cables for German university clinics for over 6 years. Their TÜV SÜD ISO 13485 audit trail and MDR compliance make customs clearance and hospital tender approval completely seamless."

DE
Dr. Hans Weber
Director of Procurement, Medizintechnik GmbH (Germany)
★★★★★

"In our Mediterranean distributor network, Medke’s NIBP cuffs and IBP adapter cables have delivered zero return rates. The connector fit with Philips and Mindray monitors is identical to OEM originals at a fraction of the budget."

CY
Elena Constantinou
Supply Chain Lead, Healthline Solutions (Cyprus)
★★★★★

"Japanese hospitals demand uncompromising mechanical finishing and clean packaging. Medke’s Class 100,000 cleanroom and biocompatibility test reports met every single requirement of our internal audit team."

JP
Kenji Takahashi
Senior Product Manager, Tokyo Medical Supplies (Japan)
★★★★★

"Fast OEM sample delivery is where Medke truly outperforms other Asian suppliers. We received custom molded telemetry cable samples in 12 days and scaled up to 30,000 units within our target launch window."

BR
Rodrigo Silveira
Chief Technology Officer, Hospicare Brasil (Brazil)
★★★★★

"Having official SFDA MDMA approval ready in Riyadh saved us over 8 months in tender preparation. Medke's team provided full technical dossier support and consistent temperature probe calibration data."

SA
Tariq Al-Mansoor
Head of Biomedical Engineering, Al-Noor Healthcare (Saudi Arabia)
★★★★★

"Our NHS trust suppliers require strict batch electrical testing and UKCA/MHRA listings. Medke's 100% Hipot screening and MedNet EC-REP credentials give our clinical procurement committee absolute peace of mind."

UK
Sarah Jenkins
Clinical Procurement Advisor, Apex Healthcare UK (United Kingdom)
Fast Factory Response

Request Direct Factory Quotations & Catalog

Connect directly with Medke’s medical engineering and export sales specialists. Receive comprehensive product catalogs, volume distributor price lists, and sample evaluation packages within 24 hours.

Guaranteed 24-Hour Quote Turnaround

Complete BOM pricing breakdown with MOQ and lead-time schedules.

Free Clinical Evaluation Samples

Available for qualified hospital tenders and medical equipment distributors.

Strict NDA & IP Protection

Full confidentiality for custom connector pinouts, moldings, and private labeling.

Direct Sales Email: info@medke.com
Factory Phone: +86 15302654212
Factory Address: Units 401 & 503, Bldg A1, Anle Ind. Zone, 172 Hangcheng Rd, Bao'an, Shenzhen, China

🔒 Strictly confidential under NDA. Your contact information is never shared with third parties.

Medke Facility Virtual Tour · Cleanroom & Automated Production

Medke Corporate Video Stream

Experience our Class 100,000 cleanroom, precision automated extrusion, laser robotic soldering, and 100% Hipot dielectric testing procedures in action.

WhatsApp