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AutoShield Trocar, Ribbed, plus Extra Cannula, 12 × 100 mm

EUDAMED

Class IIa (EU MDR)

Ref PS3561ULTNSModel 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 Trocar, Ribbed, plus Extra Cannula, 12 × 100 mm EUDAMED
Device Name
Autoshield Trocar EUDAMED
Model / Reference
TF-1020 EUDAMED
PS3561ULTNS EUDAMED

Identifiers

Primary DI / UDI-DI
35051223028315 EUDAMED
Basic UDI-DI
B-35051223028315 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 Trocar, Ribbed, plus Extra Cannula, 12 × 100 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

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 c2ebb3f4-bc6c-49a7-85ee-9b667ff96842 61 fields · synced Oct 6, 2026