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Otoscope
EUDAMEDClass I (EU MDR)
Ref 80010.311Model EJ-1、EH-2、EJ-3、EJ-4、80010.406、80010.409、80013.409、80017.409、80010.411、80013.411、80017.411、80010.309、80013.309、80010.311、80010.209、80013.209、80017.209、80010.211、80013.211、80017.211、80010.508T
Identity
- Trade Name
- Otoscope EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- EJ-1、EH-2、EJ-3、EJ-4、80010.406、80010.409、80013.409、80017.409、80010.411、80013.411、80017.411、80010.309、80013.309、80010.311、80010.209、80013.209、80017.209、80010.211、80013.211、80017.211、80010.508T EUDAMED80010.311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042831534 EUDAMED
- Basic UDI-DI
- 697604283SZ-EJPB EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Otoscope by Jiangxi China 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 | 697604283SZ-EJPB | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi China Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000037457
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 20e2b59a-d148-4131-af19-0ecb29975cb2 61 fields · synced Jun 20, 2026