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Head and neck set I
EUDAMEDClass I (EU MDR)
Ref TRO020-01Model ENT Surgical Pack
Identity
- Trade Name
- Head and neck set I EUDAMEDHead and neck set I sterile EUDAMED
- Device Name
- Head and neck set I EUDAMEDENT Surgical Pack EUDAMED
- Model / Reference
- ENT Surgical Pack EUDAMEDTRO020-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673860 EUDAMED
- Basic UDI-DI
- B-06956288673860 EUDAMED69562886IA0001JN 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
Head and neck set I 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-06956288673860 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288673860 | 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 7a6fa52d-893f-4a01-8154-0fe930898c0b 61 fields · synced Oct 6, 2026
- EUDAMED cd160103-10b9-44aa-a735-ad76812b73d3 61 fields · synced May 17, 2026