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Silicone Katheter voor Zelf-Katherisatie (Type Man-L)

EUDAMED

Class I (EU MDR)

Ref 8000015796HRef 8000015984HRef 8000015798HRef 8000015985H

by Create Medic Co., Ltd.

Identity

Trade Name
Silicone Katheter voor Zelf-Katherisatie (Type Man-L) EUDAMED
Device Name
Self-Catheterization Set EUDAMED
Model / Reference
8000015796H EUDAMED
8000015984H EUDAMED
8000015798H EUDAMED
8000015985H EUDAMED

Identifiers

Primary DI / UDI-DI
04542187220650 EUDAMED
04542187220698 EUDAMED
04542187220674 EUDAMED
04542187220704 EUDAMED
Basic UDI-DI
45421870001896 EUDAMED
EMDN Code
U010199 URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

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

Silicone Katheter voor Zelf-Katherisatie (Type Man-L) by Create Medic Co., Ltd. — Class I — 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
Create Medic Co., Ltd.
EUDAMED SRN
JP-MF-000010849
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (4)

  • EUDAMED 6654e932-24ee-4ff9-890f-583f0348488a 61 fields · synced Oct 5, 2026
  • EUDAMED 2c40b8f5-199c-4fef-8357-9e0b83bcb3b3 61 fields · synced May 17, 2026
  • EUDAMED c030ef8c-08a0-4737-9f90-c88ed2284072 61 fields · synced May 18, 2026
  • EUDAMED 54102e5e-f4ac-4c75-ad8e-82dcf16cacac 61 fields · synced May 18, 2026