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Panamax™ 48

by Hlb Panagene

Ref PNAE-1001Model PANAMAX™ 48

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88093786PNAE100ZL Basic UDI-DI 08809378689174UDI-DIDate9 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Panamax™ 48
Model / Reference
PANAMAX™ 48, PNAE-1001
Primary DI / UDI-DI
08809378689174
Basic UDI-DI
88093786PNAE100ZL
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
KR-MF-000042004
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No