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Optical Trocar, 5 x 100mm

EUDAMED

Class IIa (EU MDR)

Ref PS5525NSModel TF-1019Ref PS5525

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

Identity

Trade Name
Optical Trocar, 5 x 100mm EUDAMED
Device Name
Optical Trocar EUDAMED
Optical Trocars EUDAMED
Model / Reference
TF-1019 EUDAMED
PS5525NS EUDAMED
PS5525 EUDAMED

Identifiers

Primary DI / UDI-DI
35051223029954 EUDAMED
05051223027898 EUDAMED
Basic UDI-DI
B-35051223029954 EUDAMED
B-05051223027898 EUDAMED
EMDN Code
K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMEDEUDAMED

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

Optical Trocar, 5 x 100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and 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 (2)

  • EUDAMED 24e3eff5-a90e-4a29-9a1d-c5cb0535b79a 61 fields · synced Oct 6, 2026
  • EUDAMED 646c47eb-8636-428e-8ae5-9c02b8b45b66 61 fields · synced May 18, 2026