Identity
- Trade Name
- Fole-Safe EUDAMED
- Device Name
- Foley Catheter Securement Device EUDAMED
- Model / Reference
- CS-5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290017937007 EUDAMED
- Basic UDI-DI
- 7290017937CAT85 EUDAMED
- EMDN Code
- U0280 URETERAL CATHETERS AND STENTS - ACCESSORIES 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
Fole-Safe by Cathetrix Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7290017937CAT85 | Class I | Active |
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Manufacturer
- Manufacturer
- Cathetrix Ltd.
- EUDAMED SRN
- IL-MF-000036429
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cfede308-fc99-41aa-b4c6-57c01175f9ed 61 fields · synced Jun 18, 2026