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Surgical Skin Marker

EUDAMED

Class I (EU MDR)

Ref SU010113Model Regular tip with ruler ,Regular tip without ruler ,Fine tip with ruler, Fine tip without ruler, Mini type, Dual-tip type

by Multigate Co., Ltd

Identity

Trade Name
Surgical Skin Marker EUDAMED
Device Name
Surgical Skin Marker EUDAMED
Model / Reference
Regular tip with ruler ,Regular tip without ruler ,Fine tip with ruler, Fine tip without ruler, Mini type, Dual-tip type EUDAMED
SU010113 EUDAMED

Identifiers

Primary DI / UDI-DI
06972013960579 EUDAMED
Basic UDI-DI
697201396MU01SNNNSSM0018Z EUDAMED
Direct Marketing DI
06972013960579 EUDAMED
EMDN Code
V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED

Classification

Device Class
Class I 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

Surgical Skin Marker by Multigate 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
Multigate Co., Ltd
EUDAMED SRN
CN-MF-000002513
Authorised Representative
RFX+Care International A/S DK-AR-000001768

Sources (2)

  • EUDAMED bb9839b3-cd6f-41a8-8e58-2370fd0df07b 61 fields · synced Jun 19, 2026
  • EUDAMED 6369f741-92f4-48aa-ac1e-014832e9fd1b 61 fields · synced Jun 19, 2026