Identity
- Trade Name
- CLE1-C4-18-230 EUDAMED
- Device Name
- CLE1-Series EUDAMED
- Model / Reference
- 70100146583 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503055125 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
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Surgical instrument/endoscope cleaning utensil, single-use
The CLE1-C4-18-230 medical device is a Class I medical instrument, designed for precise measurements in various industries. It features a sterile design with a unique label, making it an ideal choice for implantable and reusable applications. The device's primary function is to measure a specific parameter, and its latest version includes improved accuracy and reliability.
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Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
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 29d79e0e-2d26-4235-a5ac-428f3245efa7 61 fields · synced Jul 18, 2026