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Otoscope
EUDAMEDClass I (EU MDR)
Ref 80010.309Model 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、80010.508TRef 80017.209Ref 80010.211Ref 80013.211Ref EJ-2Ref 80010.209Ref 80010.409Ref EJ-4Ref 80013.209Ref 80013.409Ref 80013.309
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 EUDAMED80010.309 EUDAMED80017.209 EUDAMED80010.211 EUDAMED80013.211 EUDAMEDEJ-2 EUDAMED80010.209 EUDAMED80010.409 EUDAMEDEJ-4 EUDAMED80013.209 EUDAMED80013.409 EUDAMED80013.309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042831510 EUDAMED06976042831565 EUDAMED06976042831572 EUDAMED06976042831589 EUDAMED06976042831411 EUDAMED06976042831541 EUDAMED06976042831459 EUDAMED06976042831435 EUDAMED06976042831558 EUDAMED06976042831466 EUDAMED06976042831527 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 (11)
- EUDAMED 8b6d9688-d1c4-4f36-8514-ffef7e0ea322 61 fields · synced Jul 28, 2026
- EUDAMED 57e2e3a8-749c-4f73-a1c7-ed55f5b8ab7d 61 fields · synced May 16, 2026
- EUDAMED e193127e-6541-4af6-b5c3-bb321d3403c8 61 fields · synced May 17, 2026
- EUDAMED b2f36f83-079f-4488-a277-920f97ae9651 61 fields · synced May 17, 2026
- EUDAMED b2d1f387-0b84-49b5-8c96-09c3bf186fa5 61 fields · synced May 17, 2026
- EUDAMED ba3692e6-0691-4702-a1fa-118cf4f38e89 61 fields · synced May 17, 2026
- EUDAMED 4f52f225-d9a7-4990-b1a4-3fddddc0a480 61 fields · synced May 17, 2026
- EUDAMED c98f51d9-07c7-4b83-a08f-65ec264e7b00 61 fields · synced May 18, 2026
- EUDAMED 1ed8d43d-08e2-4abf-b2ed-6fe28c192be3 61 fields · synced May 18, 2026
- EUDAMED 5290e775-3d7a-4030-bd54-06680904ce6f 61 fields · synced May 18, 2026
- EUDAMED 63f8fa59-74c9-4ddd-b958-4c3ba3c923ae 61 fields · synced May 18, 2026