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Linear Stapler Reloading Unit 45 × 3.5 mm

EUDAMED

Class IIb (EU MDR)

Ref PS9LSR45BModel TF-1045

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

Identity

Trade Name
Linear Stapler Reloading Unit 45 × 3.5 mm EUDAMED
Device Name
Linear Stapler Reloading Unit EUDAMED
Model / Reference
TF-1045 EUDAMED
PS9LSR45B EUDAMED

Identifiers

Primary DI / UDI-DI
05051223023210 EUDAMED
Basic UDI-DI
B-05051223023210 EUDAMED
EMDN Code
H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE 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

Linear Stapler Reloading Unit 45 × 3.5 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 d7053ded-c073-497d-8deb-d808ba207e3d 61 fields · synced Jun 18, 2026