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Ophthalmic Pack
EUDAMEDClass I (EU MDR)
Ref 55.5000Model Ophthalmology Surgical Pack
Identity
- Trade Name
- Ophthalmic Pack EUDAMEDOphthalmic Pack sterile EUDAMED
- Device Name
- Ophthalmic Pack EUDAMEDOphthalmology Surgical Pack EUDAMED
- Model / Reference
- Ophthalmology Surgical Pack EUDAMED55.5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673952 EUDAMED
- Basic UDI-DI
- B-06956288673952 EUDAMED69562886GA0002HW EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDFrance 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
Ophthalmic Pack 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-06956288673952 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288673952 | 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 556f8a58-521d-4666-8ad3-027fc8d3a8d1 61 fields · synced Oct 5, 2026
- EUDAMED 63e6d44e-9678-408a-b9bf-89b443b3f50d 61 fields · synced May 16, 2026