Camera Sleeve

EUDAMED

Class I (EU MDR)

Ref PS3901AModel TF1009

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

Identity

Trade Name: Camera Sleeve EUDAMED
Device Name: CAMERA SLEEVE EUDAMED
Model / Reference: TF1009 EUDAMED
PS3901A EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223032250 EUDAMED
Basic UDI-DI: B-05051223032250 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

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Camera Sleeve 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223032250	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 93ade4e0-8cec-4bbf-976e-f66461e62997 61 fields · synced Oct 7, 2026