Identity
- Device Name
- Silicone Condom Catheter EUDAMED
- Model / Reference
- Standard: 25mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977206051058 EUDAMED
- Basic UDI-DI
- 697720605Condom01KZ EUDAMED
- EMDN Code
- U0180 URETHRAL PROSTATIC AND BLADDER CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Silicone Condom Catheter by Ningbo Foyomed Medical Instruments Co., 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 | 697720605Condom01KZ | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Foyomed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032266
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 1f791129-ac5b-454c-867f-299df9810790 61 fields · synced Jun 17, 2026