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Nucleic Acid Extraction and Purification Kit (Magnetic)

by Shenzhen Sciarray Biotech Co., Ltd. 4 variants

Ref 48 tests/ kitModel Unfilled deep-well plates: 48 tests/ kit, 96 tests/ kit Pre-filled deep-well plates: 32 tests/ kit, 64 tests/ kit

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 Number697549176NAEAPK02E3 Basic UDI-DI 06975491760037UDI-DIDate24 Oct 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  • Withdrawn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
Nucleic Acid Extraction and Purification Kit (Magnetic)
Model / Reference
Unfilled deep-well plates: 48 tests/ kit, 96 tests/ kit Pre-filled deep-well plates: 32 tests/ kit, 64 tests/ kit, 48 tests/ kit
Primary DI / UDI-DI
06975491760037
Basic UDI-DI
697549176NAEAPK02E3
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038307
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Shenzhen Sciarray Biotech Co., Ltd.

See all devices from Shenzhen Sciarray Biotech 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