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Actim® PROM 1ngeni

EUDAMED

Class IVD General (EU MDR)

Ref 30831RETACRef 30832ETACRef 30831ETACRef 30834BURef 30830ETAC

by Actim Oy

Identity

Trade Name
Actim® PROM 1ngeni EUDAMED
Actim® PROM EUDAMED
Device Name
Actim® PROM 1ngeni EUDAMED
Actim® PROM EUDAMED
Model / Reference
30831RETAC EUDAMED
30832ETAC EUDAMED
30831ETAC EUDAMED
30834BU EUDAMED
30830ETAC EUDAMED

Identifiers

Primary DI / UDI-DI
D-6430030990554U9 EUDAMED
D-6430030990080TH EUDAMED
D-6430030990073TL EUDAMED
D-6430030990103T4 EUDAMED
D-6430030990455U6 EUDAMED
Basic UDI-DI
B-6430030990554U9 EUDAMED
B-6430030990080TH EUDAMED
B-6430030990073TL EUDAMED
B-6430030990103T4 EUDAMED
B-6430030990455U6 EUDAMED
EMDN Code
W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Finland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Actim® PROM 1ngeni by Actim Oy — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Actim Oy
EUDAMED SRN
FI-MF-000024323

Sources (5)

  • EUDAMED f22ed693-9394-4cce-9239-94694899a462 61 fields · synced Jul 31, 2026
  • EUDAMED c31f6250-c90f-41e7-949c-fb1ceab1ab0c 61 fields · synced May 16, 2026
  • EUDAMED d0757b75-3c25-4ce3-b2ec-484c0f225ead 61 fields · synced May 17, 2026
  • EUDAMED 57474d20-ce02-4aca-a8b7-ea4e34b3f3bc 61 fields · synced May 17, 2026
  • EUDAMED 4aef56f4-d751-4eba-8821-5d4231985347 61 fields · synced May 18, 2026