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BIP Foley Catheter - Silicone, 3-way 20 Fr 10cc
EUDAMEDClass IIb (EU MDR)
Ref 116201020 Model BIP Foley Catheter - SiliconeRef 116201010
Identity
- Trade Name
- BIP Foley Catheter - Silicone, 3-way 20 Fr 10cc EUDAMED
- Device Name
- BIP Foley Catheter - Silicone EUDAMED
- Model / Reference
- BIP Foley Catheter - Silicone EUDAMED116201020 EUDAMED116201010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333330107853 EUDAMED07333330104012 EUDAMED
- Basic UDI-DI
- 7333330FOLEYSIL120101ZR EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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
BIP Foley Catheter - Silicone, 3-way 20 Fr 10cc by Bactiguard AB — 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 | 7333330FOLEYSIL120101ZR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bactiguard AB
- EUDAMED SRN
- SE-MF-000020790
Sources (2)
- EUDAMED 26223067-92af-4e12-84c1-7dba9518871d 61 fields · synced Jul 9, 2026
- EUDAMED 47f1c589-635a-4289-8ce6-d820caef7225 61 fields · synced May 19, 2026