Identity
- Trade Name
- OPHT-5 EUDAMED
- Device Name
- ophthalmology kit EUDAMED
- Model / Reference
- GS1 China EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972823184011 EUDAMED
- Basic UDI-DI
- 697282318OPHTALKIT8G EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Opht-5 by Excellent Medical Technology Group 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 | 697282318OPHTALKIT8G | Class I | Active |
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Manufacturer
- Manufacturer
- Excellent Medical Technology Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000022462
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ee32f651-2426-4775-8410-376f9d7d0fa9 61 fields · synced Oct 6, 2026