Identity
- Device Name
- Silicone Foley Catheter EUDAMED
- Model / Reference
- FC10203DTP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675351971 EUDAMED
- Basic UDI-DI
- 697067535IMP2BSNNNSFC01VG EUDAMED
- EMDN Code
- U010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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 Foley Catheter by Integral Medical Products Co., Ltd. — Class IIb — 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 | 697067535IMP2BSNNNSFC01VG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Integral Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f595ee0c-c870-4df8-9335-205e90b5224f 61 fields · synced Jun 19, 2026