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Sterile Urethral Catheters for Single Use (silica gel without balloon)
EUDAMEDClass I (EU MDR)
Ref 6416Model 1-Way/Nelaton
Identity
- Trade Name
- Sterile Urethral Catheters for Single Use (silica gel without balloon) EUDAMED
- Device Name
- Sterile Urethral Catheters for Single Use (silica gel without balloon) EUDAMED
- Model / Reference
- 1-Way/Nelaton EUDAMED6416 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230164165 EUDAMED
- Basic UDI-DI
- 69492301GJDNG01PR EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 without balloon) by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class I — 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 | 69492301GJDNG01PR | Class I | 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 fdebc9b2-72a1-43d5-9ddf-28170f7b9c26 61 fields · synced Jul 26, 2026