Identity

Trade Name
Light Handle Cover - Dual Pack EUDAMED
Device Name
Light Handle Covers EUDAMED
Model / Reference
TF-1000 EUDAMED
PS4612 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223004356 EUDAMED
Basic UDI-DI
B-05051223004356 EUDAMED
EMDN Code
T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED

Classification

Device Class
Class I 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

Light Handle Cover - Dual Pack by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

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

Sources (1)

  • EUDAMED 8f825fef-1b3b-4f99-9ffc-fc2b5f6de60e 61 fields · synced Oct 6, 2026