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Universal set reinforced
EUDAMEDClass I (EU MDR)
Ref W910000031Model General Surgical Pack
Identity
- Trade Name
- Universal set reinforced EUDAMEDOPERO SET Universal set reinforced EUDAMED
- Device Name
- Universal set reinforced EUDAMEDGeneral Surgical Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW910000031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660259 EUDAMED
- Basic UDI-DI
- B-06956288660259 EUDAMED69562886MA0004LG EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Universal set reinforced 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-06956288660259 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288660259 | 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 c5134f35-5ba3-4f2d-a1ce-ee93b7a83b49 61 fields · synced Oct 6, 2026
- EUDAMED a5846ec2-2072-4345-95c6-bae75a7b8f9e 61 fields · synced May 19, 2026