Laparoscopic Suction/Irrigation Set with 5mm × 440mm probe, Single Spike

EUDAMED

Class IIa (EU MDR)

Ref PS3841ULTModel TF-1034

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 × 440mm probe, Single Spike EUDAMED
Device Name: Laparoscopic Suction/Irrigation Set EUDAMED
Model / Reference: TF-1034 EUDAMED
PS3841ULT EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223027645 EUDAMED
Basic UDI-DI: B-05051223027645 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

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

Laparoscopic Suction/Irrigation Set with 5mm × 440mm probe, Single 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223027645	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 8b23d837-b105-45fb-af3e-1197cfb61480 61 fields · synced Oct 6, 2026