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Linear Cutter Stapler Reloading Unit 100 × 3.8 mm

EUDAMED

Class IIb (EU MDR)

Ref PS9LCR100BModel 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 Cutter Stapler Reloading Unit 100 × 3.8 mm EUDAMED
Device Name
Linear Cutter Stapler Reloading Unit EUDAMED
Model / Reference
TF-1045 EUDAMED
PS9LCR100B EUDAMED

Identifiers

Primary DI / UDI-DI
05051223028246 EUDAMED
Basic UDI-DI
B-05051223028246 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

Yes

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 Cutter Stapler Reloading Unit 100 × 3.8 mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK…

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 a475e4f3-06b4-4252-a4d4-05d58c14db43 61 fields · synced Oct 6, 2026