Identity
- Trade Name
- Basis-Hygiene-Set EUDAMED
- Device Name
- Basis-Hygiene-Set EUDAMED
- Model / Reference
- 340571 EUDAMED340386 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858318141 EUDAMED04054858305905 EUDAMED
- Basic UDI-DI
- 4054858340571ZN EUDAMED4054858340386ZR EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Behandlungseinheit zur Vorbereitung und Durchführung von Eingriffen in der Anästhesie EUDAMEDSet zur Vorbereitung und Durchführung von Eingriffen in der Anästhesie EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Basis-Hygiene-Set 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 | 4054858340571ZN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (2)
- EUDAMED 468cead3-f535-49f8-aa88-e325a3b7e517 61 fields · synced Aug 2, 2026
- EUDAMED 158dad9e-c2ed-4078-9982-33338df2af3f 61 fields · synced May 18, 2026