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Sterile Silicone Foley Catheter
EUDAMEDClass IIa (EU MDR)
Ref FC16210D-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 EUDAMEDFC16210D-SPC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013966502 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSSF004QH EUDAMED
- Direct Marketing DI
- 06972013966502 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 IIa — 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 | 697201396MU2ASNNNSSF004QH | Class IIa | 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 (2)
- EUDAMED 91e8f6bd-4e7b-4de8-936d-818a876a96c0 61 fields · synced Jun 20, 2026
- EUDAMED 9f7444b2-586e-453c-93fc-bb1340d1c912 61 fields · synced Jun 20, 2026