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Basic set
EUDAMEDClass I (EU MDR)
Ref W911000000Model General Surgical PackRef 423328
Identity
- Trade Name
- Basic set EUDAMEDOPERO SET BASIC SET EUDAMED
- Device Name
- Basic set EUDAMEDGeneral Surgical Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW911000000 EUDAMED423328 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660167 EUDAMED06956288660624 EUDAMED
- Basic UDI-DI
- B-06956288660167 EUDAMED69562886MA0004LG EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDSpain 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
Basic 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-06956288660167 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288660167 | 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 (3)
- EUDAMED 50387832-cb50-487e-b782-f3b63d4e9f6d 61 fields · synced Oct 6, 2026
- EUDAMED c5670186-4ce0-4936-a659-ddf43e8ea2aa 61 fields · synced May 18, 2026
- EUDAMED 4d5bb61f-4fe0-4bf5-a083-870c0f2201fd 61 fields · synced May 18, 2026