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HbA1c Control

by Guangzhou Decheng Biotechnology Co., Ltd.

Ref A18QL0B

HbA1c Control (A18QL0B) is a device classified as IVD General made by Guangzhou Decheng Biotechnology Co., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-A18QL0BHM), active as of 7 Nov 2026.

Active European Union

CE IVDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-A18QL0BHM Basic UDI-DI D-A18QL0BHMUDI-DIDate6 Nov 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference
A18QL0B
Primary DI / UDI-DI
D-A18QL0BHM
Basic UDI-DI
B-A18QL0BHM
EMDN code
W0102160801 Controls immunochem - rt & poc
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000013536
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
Other properties (9, all answered No)