Identity

Trade Name
Skin Marker, Standard Tip EUDAMED
Device Name
Skin Marker, Standard Tip EUDAMED
Skin markers EUDAMED
Model / Reference
TF-1008 EUDAMED
PS3150 EUDAMED
TF1008 EUDAMED
PS3150NS EUDAMED

Identifiers

Primary DI / UDI-DI
05051223003755 EUDAMED
05051223003779 EUDAMED
Basic UDI-DI
B-05051223003755 EUDAMED
50512230SKINMARKERSJF EUDAMED
EMDN Code
V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Spain EUDAMED
Northern Ireland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMEDEUDAMED

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

Skin Marker, Standard Tip by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED 976ac894-1045-4d5d-a5a5-9ded7fdc5ec5 61 fields · synced Oct 6, 2026
  • EUDAMED 0c636130-a483-4ecc-af50-8764d41533c2 61 fields · synced May 17, 2026