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Foley Catheter
EUDAMEDClass IIa (EU MDR)
Ref 3 way Fr22Model 2 way Fr8、2 way Fr10、2 way Fr12、2 way Fr14、2 way Fr16、2 way Fr18、2 way Fr20、2 way Fr22、2 way Fr24、3 way Fr16、3 way Fr18、3 way Fr20、3 way Fr22、3 way Fr24
Identity
- Device Name
- Foley Catheter EUDAMED
- Model / Reference
- 2 way Fr8、2 way Fr10、2 way Fr12、2 way Fr14、2 way Fr16、2 way Fr18、2 way Fr20、2 way Fr22、2 way Fr24、3 way Fr16、3 way Fr18、3 way Fr20、3 way Fr22、3 way Fr24 EUDAMED3 way Fr22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926767200931 EUDAMED
- Basic UDI-DI
- 69267672001X9 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa 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
Foley Catheter by Shandong Steve Medical Science & Technology Co., Ltd. — Class IIa — 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 | 69267672001X9 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000034622
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 2fc515ad-455b-461c-875b-af8236658ba8 61 fields · synced Oct 7, 2026