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Universal Light Handle, for use with ‘DreLuxx, Skytron ANGINIEUX’

EUDAMED

Class I (EU MDR)

Ref PS9908Model 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 ‘DreLuxx, Skytron ANGINIEUX’ EUDAMED
Device Name
Universal Light Handles EUDAMED
Model / Reference
TF1012 EUDAMED
PS9908 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223008620 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

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

Universal Light Handle, for use with ‘DreLuxx, Skytron ANGINIEUX’ by Purple Surgical Holdings Limited also known as Purple Surgical International Limited…

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 38c1a631-4040-4a5b-93ef-316bc5b147ee 61 fields · synced Oct 6, 2026