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MagaBio FFPE Tissue Genomic DNA/RNA Purification Kit

by Hangzhou Bioer Technology Co., Ltd. 15 variants

Ref BSC118S1EModel BSC118T1S, BSC118S1S, BSC118M1S, BSC118N1E, BSC118T1E, BSC118S1E, BSC118M1E, BSC118L1E, BSC118T1C-C, BSC118S1C-C, BSC118M1E-T, BSC118L1E-T, BSC118S1B, BSC118M1B, BSC118S1P-A

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 Number697384322BSC118G9 Basic UDI-DI 06973843229775UDI-DIDate16 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
BSC118T1S, BSC118S1S, BSC118M1S, BSC118N1E, BSC118T1E, BSC118S1E, BSC118M1E, BSC118L1E, BSC118T1C-C, BSC118S1C-C, BSC118M1E-T, BSC118L1E-T, BSC118S1B, BSC118M1B, BSC118S1P-A
Primary DI / UDI-DI
06973843229775
Basic UDI-DI
697384322BSC118G9
Direct Marketing DI
06973843229775
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019512
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Bioer Technology Co., Ltd.

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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