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5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set

EUDAMED

Class IIa (EU MDR)

Ref PS3845ULTNSModel TF1034

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

Identity

Trade Name
5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set EUDAMED
Device Name
ULTIMATE LAPAROSCOPIC SI SETS & PROBES EUDAMED
Model / Reference
TF1034 EUDAMED
PS3845ULTNS EUDAMED

Identifiers

Primary DI / UDI-DI
35051223028575 EUDAMED
Basic UDI-DI
B-35051223028575 EUDAMED
EMDN Code
A03040299 IRRIGATION KITS, SINGLE-USE - 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

5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set 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 54f62019-348f-4ef5-94a7-027b15d41b3e 61 fields · synced Oct 9, 2026