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Sterile Silicone Foley Catheter
EUDAMEDClass IIb (EU MDR)
Ref FC16230TModel FC16230T,FC18230T,FC20230T,FC22230T,FC24230T,FC26230T,FC20250T,FC22250T,FC24260T
Identity
- Trade Name
- Sterile Silicone Foley Catheter EUDAMED
- Device Name
- Sterile Silicone Foley Catheter EUDAMED
- Model / Reference
- FC16230T,FC18230T,FC20230T,FC22230T,FC24230T,FC26230T,FC20250T,FC22250T,FC24260T EUDAMEDFC16230T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013965772 EUDAMED
- Basic UDI-DI
- 697201396MU2BSNNNSSF003RE EUDAMED
- Direct Marketing DI
- 06972013965772 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Sterile Silicone Foley Catheter by Multigate Co., Ltd — 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 | 697201396MU2BSNNNSSF003RE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED e74198fe-6229-4106-bf7d-a864f620baac 61 fields · synced Oct 6, 2026