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Automatic Nucleic Acid Workstation

by Xi'an Tianlong Science and Technology Co., Ltd. 4 variants

Ref Y025HModel PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH004YV Basic UDI-DI 06974884777898UDI-DIDate10 Jul 2023RegisteredStatusActive

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  • Withdrawn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
Automatic Nucleic Acid Workstation
Model / Reference
PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+, Y025H
Primary DI / UDI-DI
06974884777898
Basic UDI-DI
697488477TLH004YV
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001079
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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