← Back to catalogue
Sterile Silicone Foley Catheter
EUDAMEDClass IIb (EU MDR)
Ref FC14210DC-SPCModel FC12210D-SPC,FC14210D-SPC,FC16210D-SPC,FC18210D-SPC,FC20210D-SPC,FC22210D-SPC,FC24210D-SPC,FC26210D-SPC,FC16230D-SPC,FC18230D-SPC,FC20230D-SPC,FC22230D-SPC,FC24230D-SPC,FC26230D-SPC,FC14210DC-SPC,FC16210DC-SPC,FC18210DC-SPC,and so on
Identity
- Trade Name
- Sterile Silicone Foley Catheter EUDAMED
- Device Name
- Sterile Silicone Foley Catheter EUDAMED
- Model / Reference
- FC12210D-SPC,FC14210D-SPC,FC16210D-SPC,FC18210D-SPC,FC20210D-SPC,FC22210D-SPC,FC24210D-SPC,FC26210D-SPC,FC16230D-SPC,FC18230D-SPC,FC20230D-SPC,FC22230D-SPC,FC24230D-SPC,FC26230D-SPC,FC14210DC-SPC,FC16210DC-SPC,FC18210DC-SPC,and so on EUDAMEDFC14210DC-SPC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013966007 EUDAMED
- Basic UDI-DI
- 697201396MU2BSNNNSSF004RG EUDAMED
- Direct Marketing DI
- 06972013966007 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - 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 | 697201396MU2BSNNNSSF004RG | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 736b18ed-554e-4129-84e7-cd7512466d4c 61 fields · synced Jul 8, 2026
- EUDAMED a91cc917-dca2-4d4e-a1d4-1e73fe7c0bc5 61 fields · synced Jun 18, 2026