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Ophthalmology set sterile
EUDAMEDClass I (EU MDR)
Ref TRO030-01Model Ophthalmology Surgical Pack Model Ophthalmology Surgical Pack
Identity
- Trade Name
- Ophthalmology set sterile EUDAMEDOphthalmology set EUDAMED
- Device Name
- Ophthalmology Surgical Pack EUDAMEDOphthalmology set EUDAMED
- Model / Reference
- Ophthalmology Surgical Pack EUDAMEDTRO030-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673891 EUDAMED
- Basic UDI-DI
- 69562886GA0001HU EUDAMEDB-06956288673891 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Ophthalmology set sterile by Cobes Industries(Hefei) Co., Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69562886GA0001HU | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886GA0001HU | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 23b48f80-3ef6-4ee3-9384-1e4ae0681156 61 fields · synced Jul 8, 2026
- EUDAMED f4b2c3d5-88d1-4812-af27-d156d45bb15d 61 fields · synced May 18, 2026