Skip to content

PCR Supporting Equipment consumables (PCR 8 strips, PCR tubes, PCR plates, Deep well plates, ELISA plates )

by Shaoxing Genfollower Biotech Co., Ltd.

Ref PCR 8 strips PCR8WC-02TN, B20, B16, H02, H01-1, B17, H12Model PCR 8 strips:PCR8WC-02TN, PCR8WC-02BN, PCR8WC-02N , B8RT-02N, B8RT-02W, B8LT-01N, B8LT-01W, PCR-B8GC, B8LT5-01W, PCR5-B8GC, B8RT5-02W, PCR-A8TC, A8LT-01N&PCR-A8GC, A8LT-01W&PCR-A8GC, A8RT-02N&PCR-A8GC, etc, PCR tube strips, PCR plate, Deep well plate.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697858118GFPSECXV Basic UDI-DI Date11 Jul 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  • Withdrawn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 Supporting Equipment consumables (PCR 8 strips, PCR tubes, PCR plates, Deep well plates, ELISA plates )
PCR Equipment Consumables (PCR tubes strips, PCR plate, Deep well plate)
Model / Reference
PCR 8 strips:PCR8WC-02TN, PCR8WC-02BN, PCR8WC-02N, B8RT-02N, B8RT-02W, B8LT-01N, B8LT-01W, PCR-B8GC, B8LT5-01W, PCR5-B8GC, B8RT5-02W, PCR-A8TC, A8LT-01N&PCR-A8GC, A8LT-01W&PCR-A8GC, A8RT-02N&PCR-A8GC, etc, PCR 8 strips PCR8WC-02TN, PCR tube strips, PCR plate, Deep well plate., B20, B16, H02, H01-1, B17, H12
Primary DI / UDI-DI
06978581180593, 06970927943077, 06970927943022, 06970927943107, 06970927943091, 06970927943039, 06970927943114
Basic UDI-DI
697858118GFPSECXV, 697092794PCR001NT
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047835
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shaoxing Genfollower Biotech 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