Identity

Trade Name
Skin Marker, Standard Tip Plus Label EUDAMED
Device Name
Skin Market, Standard Tip, with Label EUDAMED
Model / Reference
TF-1008 EUDAMED
PS3150L EUDAMED

Identifiers

Primary DI / UDI-DI
05051223009177 EUDAMED
Basic UDI-DI
B-05051223009177 EUDAMED
EMDN Code
V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • EUDAMED 57c448a5-98f3-4e05-a488-45b2d70e850f 61 fields · synced Oct 6, 2026