Identity
- Trade Name
- Universal-Set-O EUDAMED
- Device Name
- Universal-Set-O EUDAMED
- Model / Reference
- 35438-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858029344 EUDAMED
- Basic UDI-DI
- 405485835438-2RX EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Set für operative Eingriffe und Behandlungen in der HNO EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Universal-Set-O by Fuhrmann GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
- 3 POLI-SAFE 60X45 C/ ADESIVO — Linea Sterile S.p.A. · Class I
- CustomEyes® — Beaver-Visitec International, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- LAPAROSCOPIC SLEEVE RESECTION PACK — Johnson & Johnson Medical GmbH · Class III
- KIT GINECOLOGIA LAPAROSCOPIA — Linea Sterile S.p.A. · Class I
- SET 273 Ambulant — BATIST Medical Productions s.r.o. · Class III
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 | 405485835438-2RX | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (1)
- EUDAMED f17f5779-0db1-4c70-95a5-e3d06924443e 61 fields · synced Jun 18, 2026