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Silicone Foley Catheter
EUDAMEDClass IIa (EU MDR)
Ref 91030005Model 2-way Standard: 14Fr
Identity
- Trade Name
- Silicone Foley Catheter EUDAMED
- Device Name
- Silicone Foley Catheter EUDAMED
- Model / Reference
- 2-way Standard: 14Fr EUDAMED91030005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745361460 EUDAMED
- Basic UDI-DI
- B-06972745361460 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Foley Catheter by Guangzhou Orcl Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972745361460 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Orcl Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039222
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 6cfd1fdf-6137-4539-8547-d69760e3bacc 61 fields · synced Jun 19, 2026