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Circular Stapler with Dual Safety & Tilt Top Anvil 32 mm

EUDAMED

Class IIb (EU MDR)

Ref PS9CSA32SModel 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 & Tilt Top Anvil 32 mm EUDAMED
Device Name
Circular Staplers EUDAMED
Model / Reference
TF-1048 EUDAMED
PS9CSA32S EUDAMED

Identifiers

Primary DI / UDI-DI
05051223023357 EUDAMED
Basic UDI-DI
B-05051223023357 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 & Tilt Top Anvil 32 mm 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

EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED b2a51995-beef-4bf2-a1d1-37ef75e1e612 61 fields · synced Oct 7, 2026