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Sterile All Silicone Foley Catheter
EUDAMEDClass IIb (EU MDR)
Ref HK01b18Model Sterile All Silicone Foley Catheter Two-way Standard foley catheter w/ balloon
Identity
- Device Name
- Sterile All Silicone Foley Catheter EUDAMED
- Model / Reference
- Sterile All Silicone Foley Catheter Two-way Standard foley catheter w/ balloon EUDAMEDHK01b18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883473088 EUDAMED
- Basic UDI-DI
- 697588347HK01bRD EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Sterile All Silicone Foley Catheter by Hospital & Homecare Medical Device Co., Ltd. China — 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 | 697588347HK01bRD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1fd59590-b031-4a99-ad07-2bf00692dae8 61 fields · synced Oct 6, 2026