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Stethoscope
EUDAMEDClass I (EU MDR)
Ref 003Model ZY-1001, ZY1002, ZY-1003, ZY-1004 ZY-2001, ZY-2002, ZY-2003, ZY-2004 ZY-3001, ZY-3002, ZY-3005, ZY-3006 ZY-4001, ZY-4003, ZY-4004, ZY-4007 ZY-5001, ZY-5002, ZY-5003, ZY-5004, ZY-5005, ZY-5006, ZY-5007, B06.01.002, B06.02.003, B06.01.004, B06.03.001
Identity
- Trade Name
- Stethoscope EUDAMED
- Device Name
- Stethoscope EUDAMED
- Model / Reference
- ZY-1001, ZY1002, ZY-1003, ZY-1004 ZY-2001, ZY-2002, ZY-2003, ZY-2004 ZY-3001, ZY-3002, ZY-3005, ZY-3006 ZY-4001, ZY-4003, ZY-4004, ZY-4007 ZY-5001, ZY-5002, ZY-5003, ZY-5004, ZY-5005, ZY-5006, ZY-5007, B06.01.002, B06.02.003, B06.01.004, B06.03.001 EUDAMED003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979111740010 EUDAMED
- Basic UDI-DI
- 697911174ZY01010027H EUDAMED
- Direct Marketing DI
- 06979111740010 EUDAMED
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Ningbo Ziyan Medical Equipment 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 | 697911174ZY01010027H | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Ziyan Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000049672
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED b42845b1-266f-4df8-8920-4387d1952e0e 61 fields · synced Jun 18, 2026