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Universal set sterile
EUDAMEDClass I (EU MDR)
Ref TRO010-03Model General Surgical Pack
Identity
- Trade Name
- Universal set sterile EUDAMEDUniversal set EUDAMED
- Device Name
- General Surgical Pack EUDAMEDUniversal set EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDTRO010-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660327 EUDAMED
- Basic UDI-DI
- 69562886MA0004LG EUDAMEDB-06956288660327 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
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 156d730c-8f37-4385-aa18-9761543d9cea 61 fields · synced Jul 31, 2026
- EUDAMED 96c4115e-fb26-43f5-a4d0-9fb0f330e1cb 61 fields · synced May 18, 2026