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BIP Foley Catheter - Silicone, 3-way 22 Fr 10cc
EUDAMEDClass IIb (EU MDR)
Ref 116221010 Model BIP Foley Catheter - SiliconeRef 116221020
Identity
- Trade Name
- BIP Foley Catheter - Silicone, 3-way 22 Fr 10cc EUDAMED
- Device Name
- BIP Foley Catheter - Silicone EUDAMED
- Model / Reference
- BIP Foley Catheter - Silicone EUDAMED116221010 EUDAMED116221020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333330104029 EUDAMED07333330107860 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
BIP Foley Catheter - Silicone, 3-way 22 Fr 10cc by Bactiguard AB — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
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 fdb5493b-97d4-4dcb-adc6-9b78cf100977 61 fields · synced Jul 21, 2026
- EUDAMED 01925d12-7b89-4900-8026-29baad95a69b 61 fields · synced May 19, 2026