Identity
- Trade Name
- CLE1-D2-18-230 EUDAMED
- Device Name
- CLE1-Series EUDAMED
- Model / Reference
- 70100146692 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503055149 EUDAMED
- Basic UDI-DI
- 4044503056194C EUDAMED
- EMDN Code
- V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical instrument/endoscope cleaning utensil, single-use
Cle1-D2-18-230 by FUJIFILM medwork GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
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- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
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 | 4044503056194C | Class I | Active |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (1)
- EUDAMED af8e0ee6-2b80-4d7f-b5fd-2db18ede5167 61 fields · synced Jun 19, 2026