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IMMERSIVE 360° FACTORY TOUR · VIRTUAL SHOWROOM

4,000㎡ Modern Medical Production & Cleanroom Facility

Experience our audited medical manufacturing base in Bao'an, Shenzhen. Walk through our Class 100,000 cleanrooms, automated extrusion & laser soldering lines, and TÜV SÜD audited testing laboratories in real-time 3D VR.

4,000㎡
Audited Facility
Anle Industrial Zone, Shenzhen
100,000Class
GMP Cleanroom
Positive pressure clean assembly
100%
Electrical Hipot QA
3,000V AC dielectric safety test
100+
Export Countries
EU MDR, US FDA, UK MHRA
LIVE 3D INTERACTIVEShenzhen Medke Plant · Bao'an District, Shenzhen, China
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Verified Manufacturing Capabilities

Key Production Workshops & QA Stations

Explore the precision engineering, certified cleanrooms, and stringent quality control protocols behind every Medke medical cable and patient sensor.

Class 100,000 Cleanroom Assembly Facility
Zone 01 · Clean Assembly

Class 100,000 Cleanroom Assembly Facility

Dedicated positive pressure cleanroom built to ISO 14644-1 Class 8 standards. Houses critical medical optical sensor alignment, silicon overmolding, and bio-compatible medical TPU cable termination.

Area & HVAC:1,200 ㎡ / Constant Temp 22±2℃, Humidity 45-65%
Core Operations:SpO2 LED/PD precision optical potting, Biocompatible TPU assembly
Particle Audit:< 3,520,000 particles/m³ (≥0.5µm) / Monthly 3rd-Party Test
Applicable Regs:ISO 13485:2016 Clause 6.4 (Work Environment) & EU MDR
TÜV SÜD Audited Active
Automated Extrusion & Precision Laser Soldering
Zone 02 · Extrusion & Wiring

Automated Extrusion & Precision Laser Soldering

Multi-core medical cable extrusion with Kevlar anti-tensile core braiding. Equipped with automated precision wire stripping and micro-laser welding benches to eliminate cold solder joints.

Capacity:50,000 meters / day medical cable extrusion capacity
Jacket Material:Medical-grade TPU & TPE (Latex-Free, DEHP-Free, RoHS 2.0)
Tensile & Flex:> 100,000 cycles flex fatigue life test verified
Soldering QA:100% Optical Microscope visual verification of pin joints
ISO 13485:2016 Validated
Electrical Hipot & Biocompatibility Laboratory
Zone 03 · Quality & Safety Lab

Electrical Hipot & Biocompatibility Laboratory

Comprehensive QA testing laboratory ensuring 100% compliance with IEC 60601-1 electrical safety and ISO 10993 cytotoxicity standards. Every patient cable undergoes automated multi-point testing.

Hipot Test:100% 3,000V AC Dielectric Withstand & Leakage Current test
Biocompatibility:ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation) Passed
Defibrillation:5,000V Defibrillator discharge energy absorption verification
Signal Integrity:Fluke & Mindray Patient Simulator signal accuracy benchmarked
IEC 60601-1 / FDA Clearances
Smart Barcoded ERP Warehouse & Traceability
Zone 04 · Logistics & ERP

Smart Barcoded ERP Warehouse & Traceability

Temperature and humidity controlled raw material quarantine and finished goods storage. Full ERP lot-number barcode scanning links every cable assembly to incoming raw material test batches.

Storage Capacity:500,000+ ready-to-ship standard sensor units & cables
Lot Traceability:100% Barcode ERP tracking / 10-Year DHR Record Archiving
Lead Time:24-48 Hours dispatch for standard replacement monitoring parts
Packing Standard:Anti-static sealed PE bag with medical lot traceability label
100% Lot Traceability Verified
Official Compliance Package

Download Official Factory Audit Dossier

Require certified documentation for your procurement committee, hospital tender, or regulatory registration? Request our complete audited manufacturing dossier.

  • TÜV SÜD ISO 13485:2016 Audit Summary Report

    Official surveillance audit report covering QMS design, production control, and cleanroom maintenance.

  • Class 100,000 Cleanroom Particle & Bio-Burden Report

    Third-party airborne particle counts and micro-organism sedimentation records.

  • ISO 10993 Biocompatibility & Electrical Safety Dossier

    GLP test certificates for skin irritation, cytotoxicity, and IEC 60601-1 hipot test procedures.

🛡️ Direct Confidentiality Guarantee
All proprietary technical drawings and customer references are protected. We provide mutual NDAs upon request before sharing full unredacted audit packages.
Interactive Live Tour

Schedule a 1-on-1 Live Video Guided Audit

Can't visit Shenzhen in person? Join a high-definition video walkthrough hosted by our QA Director & Lead Project Engineers via Zoom or Teams.

🔒 Your corporate details are kept strictly confidential under Medke's Privacy Policy. Our QA team responds within 2 business hours.

Global Regulatory Clearances & Certified QMS Authorities

Annual surveillance audits by TÜV SÜD (Notified Body 0123) · US FDA FEI 3012804266 · EU MDR 2017/745

Explore All 8 Certificates →
China NMPA License
China Medical
China NMPA License
粤食药监械生产许20162775号
EU MDR Class IIb QMS
European Union
EU MDR Class IIb QMS
G15 085432 0008 Rev. 00
TÜV SÜD Product Service
Notified Body 0123
TÜV SÜD Product Service
Munich, Germany · Audited
FDA 510(k) & FEI Listing
United States FDA
FDA 510(k) & FEI Listing
K152390 · K242623 · 3012804266
EN ISO 13485:2016
Medical QMS Standard
EN ISO 13485:2016
Q5 085432 0005 Rev. 05
Saudi SFDA Approval
Saudi Arabia / GCC
Saudi SFDA Approval
MDMA-2-2026-1892 (Active)
Russia Roszdravnadzor (RZN)
EAEU / Russia
Russia Roszdravnadzor (RZN)
National Medical Device Reg.
MDSAP Global Program
Global Single Audit
MDSAP Global Program
US · CA · BR · JP · AU Audited
China NMPA License
China Medical
China NMPA License
粤食药监械生产许20162775号
EU MDR Class IIb QMS
European Union
EU MDR Class IIb QMS
G15 085432 0008 Rev. 00
TÜV SÜD Product Service
Notified Body 0123
TÜV SÜD Product Service
Munich, Germany · Audited
FDA 510(k) & FEI Listing
United States FDA
FDA 510(k) & FEI Listing
K152390 · K242623 · 3012804266
EN ISO 13485:2016
Medical QMS Standard
EN ISO 13485:2016
Q5 085432 0005 Rev. 05
Saudi SFDA Approval
Saudi Arabia / GCC
Saudi SFDA Approval
MDMA-2-2026-1892 (Active)
Russia Roszdravnadzor (RZN)
EAEU / Russia
Russia Roszdravnadzor (RZN)
National Medical Device Reg.
MDSAP Global Program
Global Single Audit
MDSAP Global Program
US · CA · BR · JP · AU Audited
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