Camera Sleeve

EUDAMED

Class I (EU MDR)

Ref PS3901ANSModel TF-1009

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: TF-1009 EUDAMED
PS3901ANS EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223034049 EUDAMED
Basic UDI-DI: 50512230CAMERASLEEVESHY EUDAMED
EMDN Code: T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Spain 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

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

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	50512230CAMERASLEEVESHY	Class I	Active
EUDAMED	European Union	CE/MDR	50512230CAMERASLEEVESHY	Class I	Active

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

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 965e9eec-4f1c-4dfa-aceb-f11aee9e00a2 61 fields · synced Oct 7, 2026