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16cm Endoscopic Linear Cutter Stapler Universal Handle

EUDAMED

Class IIb (EU MDR)

Ref PS9ECHU16Model 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
16cm Endoscopic Linear Cutter Stapler Universal Handle EUDAMED
Device Name
Endoscopic Linear Cutter Stapler EUDAMED
Model / Reference
TF-1049 EUDAMED
PS9ECHU16 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223027829 EUDAMED
Basic UDI-DI
B-05051223027829 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

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

16cm 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

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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 da5eca86-8835-4102-b1db-208eb5651216 61 fields · synced Oct 8, 2026