en - Insufflation Filter/Tubing Set - Long - with Luer Lock connector

EUDAMED

Class IIa (EU MDR)

Ref PS3600LModel TF-1025

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

Identity

Trade Name: en - Insufflation Filter/Tubing Set - Long - with Luer Lock connector EUDAMED
Device Name: Insufflation Filter/Tubing Set EUDAMED
Model / Reference: TF-1025 EUDAMED
PS3600L EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223027638 EUDAMED
Basic UDI-DI: B-05051223027638 EUDAMED
EMDN Code: K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: France 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

en - Insufflation Filter/Tubing Set - Long - with Luer Lock connector 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/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223027638	Class IIa	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 00588116-889b-431c-8897-9bcf30a59348 61 fields · synced Oct 9, 2026