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Urinary Catheters for Single Use (Foley)
EUDAMEDClass IIb (EU MDR)
Ref /Model Two-Way, Three-Way; Normal Balloon, Integral Flat Balloon; Nelaton Tip, Tiemann Tip
Identity
- Device Name
- Urinary Catheters for Single Use (Foley) EUDAMED
- Model / Reference
- Two-Way, Three-Way; Normal Balloon, Integral Flat Balloon; Nelaton Tip, Tiemann Tip EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948097054176 EUDAMED
- Basic UDI-DI
- 6948097001DNGGN EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Urinary Catheters for Single Use (Foley) by Haiyan Kangyuan Medical Instrument Co., Ltd. — Class IIb — 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 | 6948097001DNGGN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Haiyan Kangyuan Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001532
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 32f6b3e3-9732-4ca5-afaa-58381214efb7 61 fields · synced Oct 7, 2026
- EUDAMED 07d75e09-be80-45a9-b05a-87777bf4f016 61 fields · synced Aug 3, 2026