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Ophthalmology set
EUDAMEDClass I (EU MDR)
Ref TRO030-02Model Ophthalmology Surgical Pack
Identity
- Trade Name
- Ophthalmology set EUDAMEDOphthalmology set sterile EUDAMED
- Device Name
- Ophthalmology set EUDAMEDOphthalmology Surgical Pack EUDAMED
- Model / Reference
- Ophthalmology Surgical Pack EUDAMEDTRO030-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673907 EUDAMED
- Basic UDI-DI
- B-06956288673907 EUDAMED69562886GA0001HU 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 by Cobes Industries(Hefei) Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06956288673907 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288673907 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- DISPOMED S.A.S FR-AR-000000891
Sources (2)
- EUDAMED 59adf0d7-751c-4667-baad-89cd9e5eb117 61 fields · synced Oct 6, 2026
- EUDAMED 6069754e-724b-4fa7-9710-00e7ea9447d3 61 fields · synced May 19, 2026