Identity
- Trade Name
- Zahnsanierungs-Set "KEM OP" EUDAMED
- Device Name
- Zahnsanierungs-Set "KEM OP" EUDAMED
- Model / Reference
- 35628-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858313801 EUDAMED
- Basic UDI-DI
- 405485835628-5SL EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Behandlungseinheit für operative Eingriffe in der Mund-Kiefer-Gesichtschirurgie EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Zahnsanierungs-Set "KEM OP" by Fuhrmann GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 405485835628-5SL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (1)
- EUDAMED 335f7f0e-b589-44e1-a752-1d196cda8755 61 fields · synced Jul 21, 2026