Universal Light Handle, for use with ‘Maquet Power LED’

EUDAMED

Class I (EU MDR)

Ref PS9925AXCOMBOModel TF1012

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

Identity

Trade Name: Universal Light Handle, for use with ‘Maquet Power LED’ EUDAMED
Device Name: Universal Light Handles EUDAMED
Model / Reference: TF1012 EUDAMED
PS9925AXCOMBO EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223027751 EUDAMED
Basic UDI-DI: 50512230LHANDLE6X EUDAMED
EMDN Code: Z12010780 SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Universal Light Handle, for use with ‘Maquet Power LED’ by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	50512230LHANDLE6X	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 cdd7f6d1-108c-41c9-ab9d-a072df2cfa8f 61 fields · synced Oct 6, 2026