Identity
- Trade Name
- Zusatz-Set EUDAMED
- Device Name
- Zusatz-Set EUDAMED
- Model / Reference
- 340461-1 EUDAMED390327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858312026 EUDAMED04054858343068 EUDAMED
- Basic UDI-DI
- 4054858340461-1H8 EUDAMED405485839032733 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Behandlungseinheit als Ergänzungsset für Behandlungen am Auge (Augenheilkunde) EUDAMEDSet für operative Eingriffe, fachabteilungsübergreifend EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Zusatz-Set by Fuhrmann GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4054858340461-1H8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (2)
- EUDAMED 7bc59d7d-918d-413e-a807-e6647a4b0177 61 fields · synced Jul 18, 2026
- EUDAMED 0074b111-4492-45de-ae34-775b56623f03 61 fields · synced May 16, 2026