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stethoscope
EUDAMEDClass I (EU MDR)
Ref 95186Model BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012Ref 400102Ref BK3007Ref BK3012Ref 401130Ref BK3001Ref 400106/BK3004Ref 3002Ref BK3005Ref BK3004
Identity
- Trade Name
- stethoscope EUDAMED
- Device Name
- stethoscope EUDAMED
- Model / Reference
- BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012 EUDAMED95186 EUDAMED400102 EUDAMEDBK3007 EUDAMEDBK3012 EUDAMED401130 EUDAMEDBK3001 EUDAMED400106/BK3004 EUDAMED3002 EUDAMEDBK3005 EUDAMEDBK3004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038610029 EUDAMED06931038600358 EUDAMED06931038630072 EUDAMED06931038630126 EUDAMED06931038610074 EUDAMED06931038631048 EUDAMED06931038600518 EUDAMED06931038604028 EUDAMED06931038630058 EUDAMED06931038630041 EUDAMED06931038610081 EUDAMED
- Basic UDI-DI
- 69310386STE0001LZ EUDAMED
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMEDGermany EUDAMEDNetherlands EUDAMEDPoland 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 (11)
- EUDAMED ca836d96-5254-4679-b309-aa82557a678d 61 fields · synced Oct 6, 2026
- EUDAMED e847230a-1199-48dc-8f54-b4bcf7431b1f 61 fields · synced May 16, 2026
- EUDAMED ab867cb0-ed95-43ce-8760-a176f8369566 61 fields · synced May 17, 2026
- EUDAMED d75c613d-46f5-43cd-961e-a538f379a075 61 fields · synced May 17, 2026
- EUDAMED 63a92099-887f-4935-a49c-09d3521438be 61 fields · synced May 17, 2026
- EUDAMED 831485cc-ce0f-4c3f-bb9a-60def15b6ca3 61 fields · synced May 17, 2026
- EUDAMED 27d5d6f7-9549-4c7b-b619-33b2d579202d 61 fields · synced May 18, 2026
- EUDAMED 6edd79f9-0c59-4570-9e8f-518c6a7d5065 61 fields · synced May 18, 2026
- EUDAMED dde4fc67-85e2-403c-b640-fcfa265f560d 61 fields · synced May 18, 2026
- EUDAMED 9363d20b-f503-464c-9e99-97befa61a1d7 61 fields · synced May 18, 2026
- EUDAMED eb646e8e-b702-4e2e-9577-4fed2d5a4d66 61 fields · synced May 19, 2026