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12mm Sliding collar fixation device

EUDAMED

Class IIa (EU MDR)

Ref PS3462FNSModel TF-1020

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

Identity

Trade Name
12mm Sliding collar fixation device EUDAMED
Device Name
Fixation Device EUDAMED
Model / Reference
TF-1020 EUDAMED
PS3462FNS EUDAMED

Identifiers

Primary DI / UDI-DI
05051223031727 EUDAMED
Basic UDI-DI
B-05051223031727 EUDAMED
EMDN Code
K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

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

12mm Sliding collar fixation device by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…

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 0df2b5c6-6e94-4327-88d7-1f1172601aa2 61 fields · synced Oct 7, 2026