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Sterile Urethral Catheters for Single Use (Double balloon)
EUDAMEDClass IIa (EU MDR)
Ref 6490Model 4-Way Male Double balloon reinforced
Identity
- Trade Name
- Sterile Urethral Catheters for Single Use (Double balloon) EUDAMED
- Device Name
- Sterile Urethral Catheters for Single Use (Double balloon) EUDAMED
- Model / Reference
- 4-Way Male Double balloon reinforced EUDAMED6490 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230164905 EUDAMED
- Basic UDI-DI
- 69492301RJDNG11VP EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Sterile Urethral Catheters for Single Use (Double balloon) by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
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 | 69492301RJDNG11VP | 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 4739c267-b45a-42a8-b9d9-100f40c9f545 61 fields · synced Jul 25, 2026