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BM 100% Silicone Foley Catheters
EUDAMEDClass IIb (EU MDR)
Ref 330 12 00 2Model 2 Way: 6FR, 8FR, 10FR, 12FR, 14FR, 16FR, 18FR, 20FR, 22FR, 24FR, 26FR 3 Way: 16FR, 18FR, 20FR, 22FR, 24FR, 26FR
Identity
- Trade Name
- BM 100% Silicone Foley Catheters EUDAMED
- Device Name
- 100% Silicone Foley Catheters EUDAMED
- Model / Reference
- 2 Way: 6FR, 8FR, 10FR, 12FR, 14FR, 16FR, 18FR, 20FR, 22FR, 24FR, 26FR 3 Way: 16FR, 18FR, 20FR, 22FR, 24FR, 26FR EUDAMED330 12 00 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382611327 EUDAMED
- Basic UDI-DI
- 697209192SFC21JA EUDAMED
- Direct Marketing DI
- 06942382611327 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
BM 100% Silicone Foley Catheters by Bonree Medical Co., Ltd. — 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 | 697209192SFC21JA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fdecbd5c-f5bc-4f63-99a2-2879a8af8340 61 fields · synced Aug 3, 2026