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DNA Isolation and Purifying kit

by Beijing OriginPoly Bio-Tec Co., Ltd. 3 variants

Ref 48 tests/kitModel (12 tests), (24 tests), (48 tests)

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 Number697513967OPBT0063M Basic UDI-DI 06975139678106UDI-DIDate30 Aug 2024RegisteredStatusActive

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  • Withdrawn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
DNA Isolation and Purifying kit
Model / Reference
(12 tests), (24 tests), (48 tests), 48 tests/kit
Primary DI / UDI-DI
06975139678106
Basic UDI-DI
697513967OPBT0063M
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000043242
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Beijing OriginPoly Bio-Tec Co., Ltd.

See all devices from Beijing OriginPoly Bio-Tec Co., Ltd. →

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