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Otoscope
EUDAMEDClass I (EU MDR)
Ref 80017.211Model 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 EUDAMED80017.211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042831596 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
Category: Otoscope, endoscopic
Otoscope by Jiangxi China Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 7de3bdb2-dc90-488f-b29e-f7ac01ff2aac 61 fields · synced Jun 18, 2026