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Sterile Silicone Foley Catheter

EUDAMED

Class IIb (EU MDR)

Ref FC16230D-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

by Multigate Co., Ltd

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 EUDAMED
FC16230D-SPC EUDAMED

Identifiers

Primary DI / UDI-DI
09341601002651 EUDAMED
Basic UDI-DI
697201396MU2BSNNNSSF004RG 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

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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 b312a582-5758-453d-bb93-a7a4ba007887 61 fields · synced Jun 18, 2026