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Handheld DOA Reader

by Assure Tech. (Hangzhou) Co., Ltd. 2 variants

Ref ADT2000Model ADT 2000

Handheld DOA Reader (ADT2000) is a Class A device made by Assure Tech. (Hangzhou) Co., Ltd., registered in EUDAMED on 30 Aug 2024 (Basic UDI-DI 695280480857K9), active as of 24 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number695280480857K9 Basic UDI-DI Date30 Aug 2024RegisteredStatusActive

Official records

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  • Withdrawn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
ADT 2000, ADT2000
Primary DI / UDI-DI
06952804834968, 06952804811105
Basic UDI-DI
695280480857K9
EMDN code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device class
Class A
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000002170
Authorised representative
Lotus NL B.V. NL-AR-000000121

Similar devices in this category

Other devices filed under VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER.

Other devices from Assure Tech. (Hangzhou) Co., Ltd.

See all devices from Assure Tech. (Hangzhou) Co., Ltd. →

Properties

  • IVD kit
  • Professional testing
  • IVD instrument
Other properties (10, all answered No)