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Skin Marker, Dual Tip

EUDAMED

Class I (EU MDR)

Ref PS3158NSModel TF1008

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 markers EUDAMED
Model / Reference
TF1008 EUDAMED
PS3158NS EUDAMED

Identifiers

Primary DI / UDI-DI
05051223009207 EUDAMED
Basic UDI-DI
50512230SKINMARKERSJF EUDAMED
EMDN Code
V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern Ireland 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

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/MDR

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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 f3a037f8-b851-4d81-9ee6-8f1ea9fc850d 61 fields · synced Oct 9, 2026