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Mobiclinic
EUDAMEDClass I (EU MDR)
Ref FD-01Model BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012
Identity
- Trade Name
- MOBICLINIC EUDAMED
- Device Name
- stethoscope EUDAMED
- Model / Reference
- BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012 EUDAMEDFD-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038631116 EUDAMED
- Basic UDI-DI
- 69310386STE0001LZ EUDAMED
- Direct Marketing DI
- 06931038631116 EUDAMED
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Mobiclinic 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 7a83531c-2dba-4d5a-9c26-0fdb56fc166d 61 fields · synced Jun 18, 2026