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Insufflation Filter/Tubing Set with Luer Lock connector

EUDAMED

Class IIa (EU MDR)

Ref PS3600NSModel TF1025

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

Identity

Trade Name
Insufflation Filter/Tubing Set with Luer Lock connector EUDAMED
Device Name
INSUFFLATION FILTERS EUDAMED
Model / Reference
TF1025 EUDAMED
PS3600NS EUDAMED

Identifiers

Primary DI / UDI-DI
35051223023983 EUDAMED
Basic UDI-DI
B-35051223023983 EUDAMED
EMDN Code
K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

No

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

Insufflation Filter/Tubing Set with Luer Lock connector by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, 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 49359cc8-1303-4172-b3f6-e95fc3498654 61 fields · synced Oct 6, 2026