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Disposable Intermittent Catheter
EUDAMEDClass I (EU MDR)
Ref PN-B10FrModel PN、PC、PS
Identity
- Trade Name
- Disposable Intermittent Catheter EUDAMED
- Device Name
- Disposable Intermittent Catheter EUDAMED
- Model / Reference
- PN、PC、PS EUDAMEDPN-B10Fr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970413351058 EUDAMED
- Basic UDI-DI
- 697041335YGR1901EUAT EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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 Hangzhou Yiguoren Biotechnology 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 | 697041335YGR1901EUAT | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Yiguoren Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003616
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED 976db61c-e2df-4837-af44-20f283f0d58f 61 fields · synced Jun 19, 2026