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Sterile Urethral Catheters for Single Use(balloon)
EUDAMEDClass IIa (EU MDR)
Ref 6341Model 2-Way Standard
Identity
- Trade Name
- Sterile Urethral Catheters for Single Use(balloon) EUDAMED
- Device Name
- Sterile Urethral Catheters for Single Use(balloon) EUDAMED
- Model / Reference
- 2-Way Standard EUDAMED6341 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230163410 EUDAMED
- Basic UDI-DI
- 69492301RJDNG02VN EUDAMED
- EMDN Code
- U010202 URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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 Urethral Catheters for Single Use(balloon) by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 69492301RJDNG02VN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangxi Yikang Medical Instrument Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000030129
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED e46467d2-7b30-4bc8-aba7-f112ded814fb 61 fields · synced Jul 30, 2026