Skip to content

PCR products

by Hangzhou Agen Biotechnology Co Ltd 31 variants

Ref PCR-96-LN-WModel PCR-96-HN-C，PCR-96-HS-C，PCR-96-HS-W-P，PCR-96R-HS-C-P，PCR-96R-HS-R-P，PCR-96R-HS-Y-P，PCR-96R-HS-B-P，PCR-96R-HS-G-P，PCR-96R1-HS-C，PCR-96-LS-W，PCR-96-LN-W，PCR-96-LN-C-P，PCR-96-LF-C-P，PCR-96-LH-C，PCR-96-HH-C，etc

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 Number697900604PCR001GM Basic UDI-DI 06979006040119UDI-DIDate8 Oct 2025RegisteredStatusActive

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  • Withdrawn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
PCR products
Model / Reference
PCR-96-HN-C，PCR-96-HS-C，PCR-96-HS-W-P，PCR-96R-HS-C-P，PCR-96R-HS-R-P，PCR-96R-HS-Y-P，PCR-96R-HS-B-P，PCR-96R-HS-G-P，PCR-96R1-HS-C，PCR-96-LS-W，PCR-96-LN-W，PCR-96-LN-C-P，PCR-96-LF-C-P，PCR-96-LH-C，PCR-96-HH-C，etc, PCR-96-LN-W
Primary DI / UDI-DI
06979006040119
Basic UDI-DI
697900604PCR001GM
EMDN Code
W0503010101 Samples analyses, glass tubes
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000049623
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Agen Biotechnology Co Ltd

See all devices from Hangzhou Agen Biotechnology Co Ltd →

Properties

  • Professional Testing

Other properties (10)

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