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Sterile Silicone Foley Catheter

EUDAMED

Class IIb (EU MDR)

Ref FC10203DTPModel FC10203DTP,FC12205DT,FC14205DT,FC16205DT,FC18205DT,FC20205DT,FC22205DT,FC24205DT,FC26205DT,FC12210DT,FC14210DT,FC16210DT,FC18210DT,FC20210DT,FC22210DT,FC24210DT,FC26210DT,FC16230DT,FC18230DT,FC20230DT,FC22230DT,FC24230DT,FC26230DT

by Multigate Co., Ltd

Identity

Trade Name
Sterile Silicone Foley Catheter EUDAMED
Device Name
Sterile Silicone Foley Catheter EUDAMED
Model / Reference
FC10203DTP,FC12205DT,FC14205DT,FC16205DT,FC18205DT,FC20205DT,FC22205DT,FC24205DT,FC26205DT,FC12210DT,FC14210DT,FC16210DT,FC18210DT,FC20210DT,FC22210DT,FC24210DT,FC26210DT,FC16230DT,FC18230DT,FC20230DT,FC22230DT,FC24230DT,FC26230DT EUDAMED
FC10203DTP EUDAMED

Identifiers

Primary DI / UDI-DI
06972013965543 EUDAMED
Basic UDI-DI
697201396MU2BSNNNSSF002RC EUDAMED
Direct Marketing DI
06972013965543 EUDAMED
EMDN Code
U010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON 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 16768a38-cd36-459e-be6b-22d38eff8b4f 61 fields · synced Oct 6, 2026