Identity

Trade Name
Optical Cannula, 5 x 70mm EUDAMED
Device Name
Optical Cannula EUDAMED
Model / Reference
TF-1019 EUDAMED
PS5537 EUDAMED
PS5537NS EUDAMED

Identifiers

Primary DI / UDI-DI
05051223031055 EUDAMED
05051223031079 EUDAMED
Basic UDI-DI
B-05051223031055 EUDAMED
B-05051223031079 EUDAMED
EMDN Code
K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

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 Cannula, 5 x 70mm 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

EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED ff255769-a4bb-4929-bebf-5c5948d5c58f 61 fields · synced Oct 6, 2026
  • EUDAMED 92f90ae4-e59e-4a2b-96ac-da07847de4b0 61 fields · synced May 19, 2026