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Reinforced Universal set
EUDAMEDClass I (EU MDR)
Ref 212109Model General Surgical Pack
Identity
- Trade Name
- Reinforced Universal set EUDAMEDReinforced Universal set steril EUDAMED
- Device Name
- Reinforced Universal set EUDAMEDGeneral Surgical Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMED212109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660402 EUDAMED
- Basic UDI-DI
- B-06956288660402 EUDAMED69562886MA0004LG EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Reinforced Universal 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-06956288660402 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288660402 | 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 6f972559-1c66-4eb1-be0f-c0a8a880ca86 61 fields · synced Oct 6, 2026
- EUDAMED 797c8aab-e795-4192-a43c-a619c57551ef 61 fields · synced May 18, 2026