10mm x 320mm Probe for PS3800A Laparoscopic Suction/Irrigation Set

EUDAMED

Class IIa (EU MDR)

Ref PS3853BModel 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: 10mm x 320mm Probe for PS3800A Laparoscopic Suction/Irrigation Set EUDAMED
Device Name: ESSENTIALS LAPAROSCOPIC SI SETS EUDAMED
Model / Reference: TF1054 EUDAMED
PS3853B EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223037170 EUDAMED
Basic UDI-DI: B-05051223037170 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

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

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Measuring Function

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Incorporates Medicinal Product

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10mm x 320mm Probe for PS3800A Laparoscopic Suction/Irrigation Set 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-05051223037170	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 282ee647-5f43-462d-8395-ded4207dc465 61 fields · synced Jun 19, 2026