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Electrosurgical Handswitch Operated Pencil

EUDAMED

Class IIb (EU MDR)

Ref PS5555Model TF-1040

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

Identity

Trade Name
Electrosurgical Handswitch Operated Pencil EUDAMED
Device Name
Electrosurgical Pencil EUDAMED
Model / Reference
TF-1040 EUDAMED
PS5555 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223004479 EUDAMED
Basic UDI-DI
B-05051223004479 EUDAMED
EMDN Code
K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED

Classification

Device Class
Class IIb 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

Electrosurgical Handswitch Operated Pencil by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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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 5b1bd6a5-b251-4e35-b0c0-d55b918b52e1 61 fields · synced Jun 18, 2026