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BIP Foley Catheter - Silicone, 3-way 24 Fr 10cc
EUDAMEDClass IIb (EU MDR)
Ref 116241010 Model BIP Foley Catheter - SiliconeRef 116241020
Identity
- Trade Name
- BIP Foley Catheter - Silicone, 3-way 24 Fr 10cc EUDAMED
- Device Name
- BIP Foley Catheter - Silicone EUDAMED
- Model / Reference
- BIP Foley Catheter - Silicone EUDAMED116241010 EUDAMED116241020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333330104036 EUDAMED07333330107877 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 24 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 5c9f674e-0d1a-48fa-ad24-e0ff93f92a2c 61 fields · synced Jul 16, 2026
- EUDAMED c6d24502-296d-4192-9477-14320c92d5cc 61 fields · synced May 18, 2026