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OP-Set (Desinfektion CZO)
EUDAMEDClass IIa (EU MDR)
Ref 340536-2Ref 33868-3Ref 390430
Identity
- Trade Name
- OP-Set (Desinfektion CZO) EUDAMEDOP-Set EUDAMED
- Device Name
- OP-Set (Desinfektion CZO) EUDAMEDOP-Set EUDAMED
- Model / Reference
- 340536-2 EUDAMED33868-3 EUDAMED390430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858315966 EUDAMED04054858312705 EUDAMED04054858342733 EUDAMED
- Basic UDI-DI
- 4054858340536-2HR EUDAMED405485833868-3T8 EUDAMED40548583904302V EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Medical Purpose
- Set zur Desinfektion der Haut und Schleimhaut. EUDAMEDSet für operative Eingriffe in der Chirurgie. EUDAMEDSet für die Durchführung eines sterilen Verbandwechsels. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
OP-Set (Desinfektion CZO) 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 | 4054858340536-2HR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (3)
- EUDAMED c5924a1d-1b6b-4b88-9c5e-9fbfa0ec11cb 61 fields · synced Oct 1, 2026
- EUDAMED e864f255-18de-47aa-91be-cc3a496ee123 61 fields · synced May 17, 2026
- EUDAMED c42c1dbe-4781-4515-adc0-c5a185ecbbd2 61 fields · synced May 18, 2026