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Substrate

by Nanjing Norman Biological Technology Co., Ltd. 3 variants

Ref 22202700100132Model Specification 1(Substrate 1:100ml,Substrate 2:100ml), Specification 2(Substrate 1:200ml,Substrate 2:200ml), Specification 3(Substrate 1:500ml,Substrate 2:500ml), Specification 4(Substrate 1:1L,Substrate 2:1L)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69218930062016E Basic UDI-DI 06921893006761UDI-DIDate7 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  • Withdrawn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
Specification 1(Substrate 1:100ml, Substrate 2:100ml), Specification 2(Substrate 1:200ml, Substrate 2:200ml), Specification 3(Substrate 1:500ml, Substrate 2:500ml), Specification 4(Substrate 1:1L, Substrate 2:1L), 22202700100132
Primary DI / UDI-DI
06921893006761
Basic UDI-DI
69218930062016E
EMDN Code
W0580 IVD general use consumables devices - other accessories
Device Class
Class A
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000024233
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Nanjing Norman Biological 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