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ProtoNano G1

EUDAMED

Class IIa (EU MDR)

Ref Ρ995G1

by Spident

Identity

Trade Name
ProtoNano G1 EUDAMED
Device Name
EsCom250 EUDAMED
Model / Reference
Ρ995G1 EUDAMED

Identifiers

Primary DI / UDI-DI
08809911112510 EUDAMED
Basic UDI-DI
880926295ECMRR EUDAMED
Direct Marketing DI
08809911112510 EUDAMED
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Greece EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

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

ProtoNano G1 by Spident — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Spident
EUDAMED SRN
KR-MF-000008691
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (1)

  • EUDAMED 3aa3cf84-232e-4e46-9617-d19288850f9d 61 fields · synced Jul 10, 2026