Get a quote
Certified Medical Quality

Certifications & Regulatory Compliance

Shenzhen Medke Technology Co., Ltd. operates under a certified ISO 13485:2016 quality management system and maintains comprehensive global regulatory approvals—including TÜV SÜD EU MDR Class IIb, EU MDR Class I DoC, US FDA 510(k), UK MHRA, Saudi SFDA, and China NMPA. We provide fully traceable, audit-ready clinical consumables for healthcare distributors, hospital tenders, and OEM partners worldwide.

Notified Body AuditTÜV SÜD (0123)Munich, Germany · Continuous annual surveillance audits
EU Medical Device Reg.MDR 2017/745Class IIb Annex IX Chapter I System & Class I Annexes II and III Declarations
US FDA Status510(k) Cleared & Reg.FEI 3012804266 · Cleared SpO2 Sensors (DQA) & NIBP Cuffs (DXQ)
Global Access6+ Major JurisdictionsActive approvals in EU, US, UK, Saudi Arabia, Russia & China
Category A · System Certifications

Quality Management System & Notified Body Certificates

Full regulatory assessment and production audits conducted by TÜV SÜD Product Service GmbH (Notified Body 0123).

QMS Standard

ISO 13485:2016 Quality Management System

Audited & Issued by TÜV SÜD Product Service GmbH (Notified Body 0123)
Valid & Active
Standard:EN ISO 13485:2016 / ISO 13485:2016
Certificate No.:Q5 085432 0005 Rev. 05
Validity Period:2026-01-17 ~ 2029-01-16
Audited Facility:Shenzhen Medke Technology Co., Ltd. (Units 401, 503, Bldg A1, Anle Ind. Zone, 172 Hangcheng Rd, Bao'an, Shenzhen)
Scope of Audit:
Design and development, production, and sales of SpO2 sensors and SpO2 extension cables, temperature probes, patient cables and leadwires, bipolar forceps cables, invasive blood pressure (IBP) cables.
Audited Activities: Design control, risk management (ISO 14971), clean assembly, lot-based traceability, calibration, and customer complaint feedback loops.
TÜV SÜD Q5 Certificate Scan Placeholder
[ Official Verified PDF · Available Upon Request ]
Audited under DAkkS accreditation
EU CE Certification

EU MDR Class IIb Quality Management System

TÜV SÜD Product Service GmbH (Notified Body 0123)
Valid & Active
Legislation:Regulation (EU) 2017/745, Annex IX Chapter I
Certificate No.:G15 085432 0008 Rev. 00
Validity Period:2026-03-23 ~ 2031-03-22
Manufacturer SRN:CN-MF-000019638
Covered Groups:
Product Group C900301: Pulse oximeter probes and SpO2 sensor series (reusable & disposable).
Product Group V030102: Temperature monitoring probes (skin & rectal/esophageal clinical series).
Assessment Conformity: Complete technical documentation assessment, post-market surveillance (PMS), and clinical evaluation conformity under EU MDR.
TÜV SÜD G15 CE MDR Certificate Scan Placeholder
[ Official Verified PDF · Available Upon Request ]
EU EUDAMED Registered Manufacturer
Category B · Market Clearances

Declarations of Conformity & International Market Registrations

Product-specific market authorizations, premarket notifications, and official health ministry approvals supporting customs clearance and distributor tenders.

EU CE Class I

EU MDR Class I Declarations of Conformity

Self-Declaration under Annexes II and III of the Regulation (EU) 2017/745
Active
Route:Annexes II and III of the Regulation (EU) 2017/745
Classification:Class I, Rule 1 (Chapter III of Annex VIII)
Registered SRN:CN-MF-000019638
5 Covered Files:• SpO2 Ext. Cable: MDR-SSEC-P0-03 v1.0 (2026-04-07)
• NIBP Cuff Series: MDR-CUFF-CE-02 v1.0
• ECG Leadwires: MDR-ECG-CE-02 v2.0
• IBP Adapter Cable: MDR-IBP-CE-02 v1.0
• Temp Ext. Cable: MDR-TPEC-T0-02 v1.0
EU Rep:MedNet EC-REP GmbH (Borkstrasse 10, 48163 Münster, Germany)
Complete Technical Files
United States

US FDA Registration & 510(k) Clearances

US Food and Drug Administration (FDA)
Active
FEI Number:3012804266
510(k) Cleared #1:K152390 (Cleared: 2016-08-18)
SpO2 Finger Clip Sensor (21 CFR 870.2700, Code DQA)
510(k) Cleared #2:K242623 (Cleared: 2024-10-31)
NIBP Blood Pressure Cuff (21 CFR 870.1120, Code DXQ)
Audit Status:Active Annual Facility Listing (FY 2026); QSR 21 CFR Part 820 compliant.
FDA Device Database Listed
United Kingdom

UK MHRA Medical Device Registration

Medicines and Healthcare products Regulatory Agency
Registered
Account Ref:0000015617
Legislation:UK Medical Devices Regulations 2002 (SI 2002 No 618)
3 Device Refs:• 2022110701283617 (ECG Leadwires)
• 2022111601285087 (SpO2 Sensors & Cuffs)
• 2021062401206748 (ECG Electrode Clips)
UK Rep:MedNet UK Ltd. (Dudley Road, Birmingham)
UK NHS Market Access
Saudi Arabia / GCC

Saudi Arabia SFDA Medical Device Approval

Saudi Food and Drug Authority (SFDA)
Active
License Type:Medical Device Marketing Authorization (MDMA)
MDMA No.:MDMA-2-2026-1892
Validity Period:2026-04-28 ~ 2029-04-28
Scope:Pulse oximeter probes and SpO2 sensor lines authorized for import, distribution, and hospital clinical use throughout the Kingdom of Saudi Arabia.
Saudi MDMA Clearance
EAEU / Russia

Russian Roszdravnadzor (RZN) Registration

Federal Service for Surveillance in Healthcare (RZN)
Active
Type:National Medical Device Registration Certificate
Registration:RZN Registered Dossier
Covered Scope:Reusable and disposable pulse oximetry sensors, patient connection cables, and adapters compatible with major Russian and international monitor brands.
Compliance:GOST R electrical safety, biocompatibility, and clinical trial conformity verified.
CIS & Hospital Tenders
China NMPA

China NMPA License & Registrations

Guangdong Provincial Medical Products Administration
Active
Mfg. License:粤食药监械生产许20162775号
Product Reg. #1:粤械注准20152071060
Product Reg. #2:粤械注准20232070034
Scope:Manufacturing license and class II device approvals for biological sensor modules, patient monitoring cables, and diagnostic accessories.
Domestic & Export Base
Regulatory Authenticity Verification: All certificates listed above are actively maintained by Shenzhen Medke Technology Co., Ltd. For tender verification or third-party audits, certificate validity may be confirmed directly on the official portals of TÜV SÜD (Certificate Explorer), the US FDA Establishment Registration database (FEI: 3012804266), the UK MHRA Public Access Database, or the Saudi SFDA MDMA register.
Category C · Audited Infrastructure

Manufacturing Facilities & Quality Control Operations

Our certified manufacturing operations in Shenzhen, China are built and operated strictly in compliance with TÜV SÜD audited site boundaries and ISO 13485 cleanroom procedures.

Audited Manufacturing Site

TÜV SÜD & ISO 13485 Audited Facility

Medke's production facility spans multiple specialized manufacturing floors dedicated to precision soldering, high-frequency shielding, biocompatible silicone/TPU overmolding, clean optical sensor assembly, and 100% finished electrical testing.

  • ✓Clean Optical Assembly Rooms: Controlled micro-environment for optical emitter and photodiode precision alignment on SpO2 sensors.
  • ✓100% Full-Batch Traceability: Device Master Records (DMR) and Device History Records (DHR) maintained with batch numbering on raw cables, raw connectors, and finished devices.
  • ✓In-House Rigorous Mechanical Testing: Cable flexing endurance (>10,000 cycles), connector mating retention, tensile pull strength, and high-voltage insulation breakdown test bench.

Official Audit Premises (TÜV SÜD Q5 085432 0005)

Shenzhen Medke Technology Co., Ltd.
Units 401 & 503, Building A1, Anle Industrial Zone,
No. 172 Hangcheng Road, Xixiang Street, Bao'an District,
Shenzhen 518102, Guangdong, P.R. China

Audited Functions on Record:
Management responsibility, Design & Engineering, Raw Material QC, Cleanroom Production, Final Inspection, Packaging, Clean Storage, and Global Logistics.
Pillar 01

Raw Material Biocompatibility

All patient-contact silicones, TPU jackets, and adhesives comply with medical-grade non-cytotoxic, non-irritant, and non-sensitizing requirements.

Pillar 02

100% Signal Integrity Verification

Each finished SpO2 and ECG cable undergoes automated continuity, pinout resistance, insulation resistance, and simulated patient monitor signal verification.

Pillar 03

TÜV SÜD Annual Surveillance

Subjected to rigorous annual on-site surveillance audits and periodic unannounced inspections by TÜV SÜD Munich to guarantee ongoing standard conformance.

Pillar 04

Clinical Compatibility Testing

Tested for seamless mechanical plug-and-play fit and optical wavelength parity against leading OEM patient monitors (Philips, Mindray, GE, Dräger, Masimo, Nellcor).

Distributor & Hospital Tender Support

Request Official Certificate Copies & Compliance Dossier

Are you preparing a national hospital tender submission, distributor registration dossier, or customs clearance package?

Submit your business requirements below to receive unredacted, high-resolution official PDF certificate copies, DoC declarations, and technical dossiers verified by our regulatory affairs department.

  • Verified response within 1 business day (Hong Kong/Shenzhen UTC+8)
  • Non-Disclosure Agreements (NDA) available upon request
  • Direct communication with Medke senior regulatory affairs team
Strict B2B confidentiality guaranteed

Request Certificate Dossier

Please fill in your company information to receive the certified documents.

We respect your business privacy. Your contact information is used exclusively to fulfill your compliance documentation request according to our Privacy Policy.

WhatsApp