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Silicone Condom Catheter
EUDAMEDClass I (EU MDR)
Ref standard: 29mm Model Standard: 25mm Ref standard:41mmRef standard: 32mm
Identity
- Device Name
- Silicone Condom Catheter EUDAMED
- Model / Reference
- Standard: 25mm EUDAMEDstandard: 29mm EUDAMEDstandard:41mm EUDAMEDstandard: 32mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977206051065 EUDAMED06977206051096 EUDAMED06977206051072 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 (3)
- EUDAMED a5bc5790-514c-4508-ade6-9c59e0d9ae52 61 fields · synced Oct 6, 2026
- EUDAMED 2ea364f7-4390-4b16-b409-1ac94b463b63 61 fields · synced May 17, 2026
- EUDAMED 145d266f-03c4-47a6-89ee-2960b5656ea0 61 fields · synced May 18, 2026