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Reinforced Universal set sterile
EUDAMEDClass I (EU MDR)
Ref TRO010-04Model General Surgical Pack
Identity
- Trade Name
- Reinforced Universal set sterile EUDAMEDReinforced Universal set EUDAMED
- Device Name
- General Surgical Pack EUDAMEDReinforced Universal set EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDTRO010-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660334 EUDAMED
- Basic UDI-DI
- 69562886MA0004LG EUDAMEDB-06956288660334 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
Reinforced Universal 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 | 69562886MA0004LG | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0004LG | 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 03b93d86-3602-4809-97c2-1117cd3af6a8 61 fields · synced Oct 6, 2026
- EUDAMED f0d5dbc7-6a04-405c-8837-baf3b5528a18 61 fields · synced May 17, 2026