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Disposable Intermittent Catheter
EUDAMEDClass I (EU MDR)
Ref H09-22FLUModel balltip,uncoated TPU catheter
Identity
- Trade Name
- Disposable Intermittent Catheter EUDAMED
- Device Name
- Disposable Intermittent Catheter EUDAMED
- Model / Reference
- balltip,uncoated TPU catheter EUDAMEDH09-22FLU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942214122632 EUDAMED
- Basic UDI-DI
- 697197678DXACE0116VR EUDAMED
- EMDN Code
- U010199 URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Disposable Intermittent Catheter by Chengdu Daxan Innovative Medical Tech.Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697197678DXACE0116VR | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu Daxan Innovative Medical Tech.Co., Ltd
- EUDAMED SRN
- CN-MF-000033805
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6bb5dafd-07f9-47bb-9cbc-e5b0e902fb67 61 fields · synced Jun 18, 2026