Identity

Trade Name
Light Handle Cover EUDAMED
Device Name
LIGHT HANDLE COVERS EUDAMED
Model / Reference
TF1000 EUDAMED
PS4611 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223004332 EUDAMED
Basic UDI-DI
B-05051223004332 EUDAMED
EMDN Code
T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern Ireland 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

Light Handle Cover 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/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED 0f76bbd2-7aeb-4568-adf0-274b479a4816 61 fields · synced Jun 18, 2026