Identity
- Trade Name
- Video Colposcope EUDAMED
- Device Name
- Video Colposcope EUDAMED
- Model / Reference
- C3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413801745 EUDAMED
- Basic UDI-DI
- 69444138C3SYY EUDAMED
- EMDN Code
- Z12020703 COLPOSCOPES 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
Video Colposcope by Edan Instruments, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151878 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69444138C3SYY | Class I | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 9a9784b1-857c-490d-a1f3-44e26a2c41bd 85 fields · synced Jun 18, 2026
- FDA 510(k) K151878 1 fields · synced May 18, 2026