Identity

Trade Name
Smoke Filter EUDAMED
Device Name
SMOKE FILTER EUDAMED
Model / Reference
TF1010 EUDAMED
PS3604NS EUDAMED

Identifiers

Primary DI / UDI-DI
05051223024019 EUDAMED
Basic UDI-DI
50512230SMOKEFILTERSJ3 EUDAMED
EMDN Code
K02010107 SMOKE EVACUATION SYSTEMS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Smoke Filter by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

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

Sources (1)

  • EUDAMED 81478898-86d5-40ab-94f0-8b75feb53af8 61 fields · synced Oct 6, 2026