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Silicone Urethral Catheter
EUDAMEDClass IIa (EU MDR)
Ref EC020112SYModel 1 Way 4.0mm(12Fr）
Identity
- Trade Name
- Silicone Urethral Catheter EUDAMED
- Device Name
- Silicone Urethral Catheter EUDAMED
- Model / Reference
- 1 Way 4.0mm(12Fr） EUDAMEDEC020112SY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941951012619 EUDAMED
- Basic UDI-DI
- B-06941951012619 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Urethral Catheter by Guangdong Ecan 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-06941951012619 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Ecan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020906
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 5b74c049-d3d1-4a50-9cdf-2ef5489b6996 61 fields · synced Jun 19, 2026