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Sterile Urethral Catheters for Single Use (silica gel with balloon)
EUDAMEDClass IIb (EU MDR)
Ref 6397Model 2-Way common
Identity
- Trade Name
- Sterile Urethral Catheters for Single Use (silica gel with balloon) EUDAMED
- Device Name
- Sterile Urethral Catheters for Single Use (silica gel with balloon) EUDAMED
- Model / Reference
- 2-Way common EUDAMED6397 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230163977 EUDAMED
- Basic UDI-DI
- 69492301GJDNG02PT EUDAMED
- EMDN Code
- U010202 URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON 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 Urethral Catheters for Single Use (silica gel with balloon) by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class IIb — 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 | 69492301GJDNG02PT | Class IIb | 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 d6df5828-a536-4986-b7dd-6362d50e86bc 61 fields · synced Jul 13, 2026