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Circular Stapler with Dual Safety 32 mm

EUDAMED

Class IIb (EU MDR)

Ref PS9CS32SModel TF-1048

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

Identity

Trade Name
Circular Stapler with Dual Safety 32 mm EUDAMED
Device Name
Circular Stapler EUDAMED
Model / Reference
TF-1048 EUDAMED
PS9CS32S EUDAMED

Identifiers

Primary DI / UDI-DI
05051223023302 EUDAMED
Basic UDI-DI
B-05051223023302 EUDAMED
EMDN Code
H0202020201 SINGLE-USE CURVED CIRCULAR STAPLERS FOR OPEN SURGERY 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

Circular Stapler with Dual Safety 32 mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited…

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 f13c55a6-ec2b-4a3b-9a50-14184099de66 61 fields · synced Oct 6, 2026