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Laparoscopic Suction/Irrigation Set with 5mm x 320mm probe, Dual Spike

EUDAMED

Class IIa (EU MDR)

Ref PS3800AModel TF1054

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

Identity

Trade Name
Laparoscopic Suction/Irrigation Set with 5mm x 320mm probe, Dual Spike EUDAMED
Device Name
Laparoscopic Suction/Irrigation Set EUDAMED
Model / Reference
TF1054 EUDAMED
PS3800A EUDAMED

Identifiers

Primary DI / UDI-DI
05051223032076 EUDAMED
Basic UDI-DI
B-05051223032076 EUDAMED
EMDN Code
A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED

Classification

Device Class
Class IIa 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

Laparoscopic Suction/Irrigation Set with 5mm x 320mm probe, Dual Spike by Purple Surgical Holdings Limited also known as Purple Surgical International…

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 bbd71803-9435-44de-9350-4f53cff44efa 61 fields · synced Oct 6, 2026