Identity
- Device Name
- Silicone Foley Catheter EUDAMED
- Model / Reference
- FC16230T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675357713 EUDAMED
- Basic UDI-DI
- 697067535IMP2BSNNNSFC02VJ EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Silicone Foley Catheter by Integral Medical Products Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
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 | 697067535IMP2BSNNNSFC02VJ | 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 f47f4dbc-8089-43c5-bbf5-54da4c80f796 61 fields · synced Aug 4, 2026