Identity
- Trade Name
- HSK-Set EUDAMED
- Device Name
- HSK-Set EUDAMED
- Model / Reference
- 390198-2 EUDAMED390198-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858340807 EUDAMED04054858313320 EUDAMED
- Basic UDI-DI
- 4054858390198-2LN EUDAMED4054858390198-1LL EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Set zur Hysteroskopie (transvaginale Betrachtung der Gebärmutterinnenseite mittels eines Endoskops) EUDAMEDBehandlungseinheit zur Hysteroskopie (transvaginale Betrachtung der Gebärmutterinnenseite mittels eines Endoskops) EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
HSK-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 | 4054858390198-2LN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (2)
- EUDAMED 294258aa-04cf-4511-b502-737473c444fd 61 fields · synced Jul 25, 2026
- EUDAMED 3926f9e7-f164-4d07-ad02-6a79f66d7b79 61 fields · synced May 18, 2026