Monopolar LapClinch with On/Off Ratchet, 5mm/33cm

EUDAMED

Class IIb (EU MDR)

Ref PS4554PModel TF-1036

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

Identity

Trade Name: Monopolar LapClinch with On/Off Ratchet, 5mm/33cm EUDAMED
Device Name: Monopolar Lapclinch EUDAMED
Model / Reference: TF-1036 EUDAMED
PS4554P EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223028024 EUDAMED
Basic UDI-DI: B-05051223028024 EUDAMED
EMDN Code: K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: France 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

Monopolar LapClinch with On/Off Ratchet, 5mm/33cm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK…

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-05051223028024	Class IIb	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 cb38b64c-11ca-4632-9dcc-9d99368b3125 61 fields · synced Oct 8, 2026