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gen100

EUDAMED

Class IIa (EU MDR)

Ref 30010150,30010150LP,30010150BK

by Pollogen Ltd

Identity

Device Name
gen100 EUDAMED
Model / Reference
30010150,30010150LP,30010150BK EUDAMED

Identifiers

Primary DI / UDI-DI
17290016586265 EUDAMED
Basic UDI-DI
B-17290016586265 EUDAMED
EMDN Code
Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

Yes

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

gen100 by Pollogen Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Pollogen Ltd
EUDAMED SRN
IL-MF-000031034
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED 47ceda37-4839-44b7-9c9b-95d24b5f79dc 61 fields · synced Jun 19, 2026
  • EUDAMED 47ceda37-4839-44b7-9c9b-95d24b5f79dc-1 61 fields · synced Jun 10, 2026