Skin Marker, Dual Tip

EUDAMED

Class I (EU MDR)

Ref PS3158Model TF-1008

by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Identity

Trade Name: Skin Marker, Dual Tip EUDAMED
Device Name: Skin Marker, Dual Tip EUDAMED
Model / Reference: TF-1008 EUDAMED
PS3158 EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223003816 EUDAMED
Basic UDI-DI: B-05051223003816 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

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223003816	Class I	Active

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Manufacturer

Manufacturer: Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
EUDAMED SRN: GB-MF-000012819
Authorised Representative: Advena Limited MT-AR-000000234

Sources (1)

EUDAMED 079c1787-a3a3-42d0-8c2d-169283b75da6 61 fields · synced Oct 8, 2026