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Otolaryngological set
EUDAMEDClass I (EU MDR)
Ref W914000007Model ENT Surgical Pack
Identity
- Trade Name
- Otolaryngological set EUDAMEDOPERO SET OTOLARYNGOLOGICAL SET EUDAMED
- Device Name
- Otolaryngological set EUDAMEDENT Surgical Pack EUDAMED
- Model / Reference
- ENT Surgical Pack EUDAMEDW914000007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660136 EUDAMED
- Basic UDI-DI
- B-06956288660136 EUDAMED69562886IA0001JN EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDFrance 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
Otolaryngological 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-06956288660136 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288660136 | 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 13bd6727-0df4-433b-98ed-38217f7d828c 61 fields · synced Jul 12, 2026
- EUDAMED 4bb8a5cc-df25-4d31-8ccd-0efde50f884e 61 fields · synced May 18, 2026