06cm Endoscopic Linear Cutter Stapler Universal Handle

EUDAMED

Class IIb (EU MDR)

Ref PS9ECHU06Model TF-1049

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

Identity

Trade Name: 06cm Endoscopic Linear Cutter Stapler Universal Handle EUDAMED
Device Name: Endoscopic Linear Cutter Stapler EUDAMED
Model / Reference: TF-1049 EUDAMED
PS9ECHU06 EUDAMED

Identifiers

Primary DI / UDI-DI: 05051223027812 EUDAMED
Basic UDI-DI: B-05051223027812 EUDAMED
EMDN Code: H020301040102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY 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

06cm Endoscopic Linear Cutter Stapler Universal Handle by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple…

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-05051223027812	Class IIb	Active

Is this your device? Claim it to add documentation and request validation.

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 1b6b8057-5290-4e6a-a5a2-c4d7ddceab45 61 fields · synced Oct 6, 2026