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PCR products

by Hangzhou Agen Biotechnology Co Ltd China EUDAMED

Ref PCR-402-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

EMDN W0503010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697900604PCR001GM Basic UDI-DIDate8 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

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-402-W
Primary DI / UDI-DI
06979006040188
Basic UDI-DI
697900604PCR001GM
EMDN Code
W0503010101 Samples analyses, glass tubes
Device Class
Class A
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 5033ff43-e32b-48ff-9ab9-f87452820d7b 61 fields · synced 22 Oct 2026