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SET DESECHABLE Extra Grueso 4.7X95MM
EUDAMEDClass IIa (EU MDR)
Ref BAE095.47
by Prim, S.a.
Identity
- Trade Name
- SET DESECHABLE Extra Grueso 4.7X95MM EUDAMED
- Device Name
- Agrupaciones Fresas ORL EUDAMED
- Model / Reference
- BAE095.47 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048380107 EUDAMED
- Basic UDI-DI
- 843404825KITFRESADOORLKY EUDAMED
- EMDN Code
- Q030302 ENT SURGERY BURS AND HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Agrupaciones de productos para cirugía de ORL que incluyen una fresa de dimensiones y material variable junto a un tubo de irrigación de bomba peristáltica EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
SET DESECHABLE Extra Grueso 4.7X95MM by Prim S.a. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843404825KITFRESADOORLKY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-PR-000004648
Sources (1)
- EUDAMED 3a596ae5-7bc0-4175-bcf9-b2eb899c2da7 61 fields · synced Jul 26, 2026