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Viral DNA and RNA Extraction Kit, Viral DNA and RNA Extraction Kit (Panall 8000 MD System, Pre-filled)

by Xi'an Tianlong Science and Technology Co., Ltd. 9 variants

Ref T038H, T323H, T041H, T108H, T528H, T506H, T049H, T050H, T392H, T518H, T060H, T324H, T338H, T322H, T325H, T052H, T339H, T373H, T393H

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH009Z7 Basic UDI-DI Date15 Aug 2022RegisteredStatusActive

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  • Withdrawn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
Viral DNA and RNA Extraction Kit, Viral DNA and RNA Extraction Kit (Panall 8000 MD System, Pre-filled)
Model / Reference
T038H, T323H, T041H, T108H, T528H, T506H, T049H, T050H, T392H, T518H, T060H, T324H, T338H, T322H, T325H, T052H, T339H, T373H, T393H
Primary DI / UDI-DI
06974884777447, 06974884777348, 06974884777430, 06974884777379, 06974884777195, 06974884777263, 06974884777423, 06974884777416, 06974884777294, 06974884777201, 06974884777386, 06974884777331, 06974884777317, 06974884777355, 06974884777324, 06974884777393, 06974884777300, 06974884777065, 06974884777287
Basic UDI-DI
697488477TLH009Z7
EMDN Code
W0104080699 Nucleic acid identification (bacteriology) manual / automated - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

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

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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