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AutoShield Trocars, Ribbed, 5 & 10 × 100 mm, plus Extra Cannulas

EUDAMED

Class IIa (EU MDR)

Ref PS3569ULTNSModel 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
AutoShield Trocars, Ribbed, 5 & 10 × 100 mm, plus Extra Cannulas EUDAMED
Device Name
Autoshield Trocar EUDAMED
Model / Reference
TF-1020 EUDAMED
PS3569ULTNS EUDAMED

Identifiers

Primary DI / UDI-DI
35051223028391 EUDAMED
Basic UDI-DI
B-35051223028391 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

AutoShield Trocars, Ribbed, 5 & 10 × 100 mm, plus Extra Cannulas by Purple Surgical Holdings Limited also known as Purple Surgical International 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 7a70c975-d2a9-4a35-9470-45251f34fabc 61 fields · synced Oct 6, 2026