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Sterile Urethral Catheters for Single Use (silica gel with balloon)

EUDAMED

Class IIb (EU MDR)

Ref 6410Model 3-Way common

by Jiangxi Yikang Medical Instrument Group Co., Ltd.

Identity

Trade Name
Sterile Urethral Catheters for Single Use (silica gel with balloon) EUDAMED
Device Name
Sterile Urethral Catheters for Single Use (silica gel with balloon) EUDAMED
Model / Reference
3-Way common EUDAMED
6410 EUDAMED

Identifiers

Primary DI / UDI-DI
06949230164103 EUDAMED
Basic UDI-DI
69492301GJDNG04PX EUDAMED
EMDN Code
U010204 URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Bulgaria 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 Urethral Catheters for Single Use (silica gel with balloon) by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class IIb — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000030129
Authorised Representative
phoenix Medtech GmbH DE-AR-000007996

Sources (1)

  • EUDAMED 06d88b6c-4df8-4199-b777-65bee27c7836 61 fields · synced Jun 18, 2026