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Nucleic Acid Extraction Kit

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

Active European Union

Ref T111H, T530H, T531H, T135H, T136H, T546H, T171H, T137H, T850H, T123H, T151H, T513H, T839H, T153H, T173H, T551H, T533H, T132H, T165H, T113H, T112H, T847H, T901H, T057H, T163H, T321H, T512H, T526H, T532H, T201H, T182H, T529H, T525H, T849H, T562H, T390H, T552H, T548H, T557H, T191H

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH008Z5 Basic UDI-DIDate22 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Nucleic Acid Extraction Kit
Model / Reference
T111H, T530H, T531H, T135H, T136H, T546H, T171H, T137H, T850H, T123H, T151H, T513H, T839H, T153H, T173H, T551H, T533H, T132H, T165H, T113H, T112H, T847H, T901H, T057H, T163H, T321H, T512H, T526H, T532H, T201H, T182H, T529H, T525H, T849H, T562H, T390H, T552H, T548H, T557H, T191H
Primary DI / UDI-DI
06974884777003, 06974884776587, 06974884776570, 06974884776914, 06974884776471, 06974884776532, 06974884776792, 06974884776488, 06974884776372, 06974884776952, 06974884776860, 06974884776648, 06974884776419, 06974884776846, 06974884776778, 06974884776303, 06974884776556, 06974884776938, 06974884776808, 06974884776983, 06974884776990, 06974884776396, 06974884776365, 06974884777041, 06974884776815, 06974884776693, 06974884776655, 06974884776617, 06974884776563, 06974884776716, 06974884776747, 06974884776594, 06974884776624, 06974884776389, 06974884776457, 06974884776686, 06974884776297, 06974884776518, 06974884776464, 06974884776730
Basic UDI-DI
697488477TLH008Z5
EMDN Code
W0104080699 Nucleic acid identification (bacteriology) manual / automated - other
Device Class
Class A
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