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Seesheen
EUDAMEDClass I (EU MDR)
Ref EN-14Model EN-14X, EN-14X plus, EN-14, EN-14 plus, EN-14HX, EN-14HX plus, EN-14H, EN-14H plus
Identity
- Trade Name
- SEESHEEN EUDAMED
- Device Name
- Video Rhinolaryngoscope EUDAMED
- Model / Reference
- EN-14X, EN-14X plus, EN-14, EN-14 plus, EN-14HX, EN-14HX plus, EN-14H, EN-14H plus EUDAMEDEN-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970680130653 EUDAMED
- Basic UDI-DI
- 69706801322ENAW EUDAMED
- Direct Marketing DI
- 06970680130653 EUDAMED
- EMDN Code
- Z12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Seesheen by Zhuhai Seesheen Medical Technology Co., Ltd. — Class I — CE/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 | 69706801322ENAW | Class I | Active |
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Manufacturer
- Manufacturer
- Zhuhai Seesheen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027274
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 90b9542d-958d-4f79-9a9b-0df3a92c5287 61 fields · synced Oct 7, 2026