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Universal slit sheet set
EUDAMEDClass I (EU MDR)
Ref TRO010-06Model General Surgical Pack
Identity
- Trade Name
- Universal slit sheet set EUDAMEDUniversal slit sheet set sterile EUDAMED
- Device Name
- Universal slit sheet set EUDAMEDGeneral Surgical Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDTRO010-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660358 EUDAMED
- Basic UDI-DI
- B-06956288660358 EUDAMED69562886MA0004LG 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 slit sheet 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-06956288660358 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288660358 | 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 568b3220-3aea-47c8-a900-835ce2f9ad2b 61 fields · synced Jul 24, 2026
- EUDAMED f7a28fc3-7ee9-446c-9c34-14303447fe27 61 fields · synced May 17, 2026