Identity
- Trade Name
- Kunststoffschale 250ml, gelb, st. EUDAMED
- Device Name
- Kunststoffschale 250ml, gelb, st. EUDAMED
- Model / Reference
- 300025-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858320601 EUDAMED
- Basic UDI-DI
- 4054858300025-1DG EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Einmal-Kunststoffschalen dienen sowohl als Auffangbehältnisse für Blut, Wundsekret und sonstiger Körperflüssigkeiten, als auch zum Ablegen benutzter Instrumente und Materialien. Kunststoffschalen können weiterhin zur Lagerung von Flüssigkeiten (z.B. Desinfektionslösung) verwendet werden. Die Schutzunterlage dient der optimalen aseptischen Präsentation der Einmal-Kunststoffschalen. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Kunststoffschale 250ml, gelb, st. 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 | 4054858300025-1DG | 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 d18ad858-6a05-4188-a8e8-e228a4b2ab50 61 fields · synced Jul 23, 2026