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PrimaDent Spray Neutral

by PRISMAN GmbH 3 variants

Ref PRIMAD124, 70004016Model 575, IDP 700 conc.

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number++EPRM575EQ Basic UDI-DI 04064797029398UDI-DIDate22 Sep 2026RegisteredStatusActive
European UnionCE/MDR Number++EPRM575EQ Basic UDI-DI 04064797029398UDI-DIDate22 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
PrimaDent Spray Neutral
gigasept pearls
Device Name
Sprüh- und Wischdesinfektion BIO RSD 410
Instrumentendesinfektion POW(D)ER HIGH Konz., IDP 700 conc.
Model / Reference
575, PRIMAD124, IDP 700 conc., 70004016
Primary DI / UDI-DI
04064797029398
Basic UDI-DI
++EPRM575EQ, B-04064797029398
EMDN Code
D99, D0599
Device Class
Class IIa
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000009900

Other devices from PRISMAN GmbH

See all devices from PRISMAN GmbH →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No