Universal Light Handle, for use with ‘Maquet PRX 4000/6000’

EUDAMED

Class I (EU MDR)

Ref PS9925DCOMBOModel 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 PRX 4000/6000’ EUDAMED
Device Name: Universal Light Handles EUDAMED
Model / Reference: TF1012 EUDAMED
PS9925DCOMBO EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223027768 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 PRX 4000/6000’ 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 028fbadd-063a-47c5-91a7-04b0fb74733f 61 fields · synced Jun 18, 2026