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stethoscope
EUDAMEDClass I (EU MDR)
Ref BK3008Model BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012
Identity
- Trade Name
- stethoscope EUDAMED
- Device Name
- stethoscope EUDAMED
- Model / Reference
- BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012 EUDAMEDBK3008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038630089 EUDAMED
- Basic UDI-DI
- 69310386STE0001LZ EUDAMED
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
stethoscope by Wenzhou Bokang Instruments Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69310386STE0001LZ | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Bokang Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000021505
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 266f2b3c-3fae-4814-8e5d-2978d8b76ba8 61 fields · synced Jun 18, 2026