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Self-Catheterization Set (Male L Type)

EUDAMED

Class I (EU MDR)

Ref 8000016008Ref 8000016009Ref 8000016010Ref 8000016007Ref 8000016006

by Create Medic Co., Ltd.

Identity

Trade Name
Self-Catheterization Set (Male L Type) EUDAMED
Device Name
Self-Catheterization Set EUDAMED
Model / Reference
8000016008 EUDAMED
8000016009 EUDAMED
8000016010 EUDAMED
8000016007 EUDAMED
8000016006 EUDAMED

Identifiers

Primary DI / UDI-DI
04542187216714 EUDAMED
04542187216721 EUDAMED
04542187216738 EUDAMED
04542187216707 EUDAMED
04542187216691 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

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

Self-Catheterization Set (Male L Type) 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 (5)

  • EUDAMED 011ab42b-3186-464b-892a-dc1e128e0a54 61 fields · synced Aug 2, 2026
  • EUDAMED 7be2590a-b08f-4b81-ad26-2ceab35f5ca8 61 fields · synced May 17, 2026
  • EUDAMED ddbfd4f8-084b-4bde-9de4-6b86d5d18f04 61 fields · synced May 17, 2026
  • EUDAMED 1e30fe6e-e98f-409e-b5e8-51ca2558f805 61 fields · synced May 19, 2026
  • EUDAMED 77b1cd2a-efa5-411a-9db8-96edd2f66c33 61 fields · synced May 19, 2026