Skip to content

Blood Glucose Meter

by Bioland Technology Ltd.

Ref G-425-2Model G-427B,G-425-2

Active European Union. Also listed in GUDID (US).

CE IVDR CE IVDD

Valid until

16 Apr 2030

CE IVDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED Number6939184630001BD Basic UDI-DI Date4 Jun 2025RegisteredStatusActive
European UnionCE/IVDR EUDAMED Number6939184630001BD Basic UDI-DI Date4 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06939184631530 UDI-DI Date26 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Blood Glucose Meter EUDAMED
Bioland GUDID
Generic Name
Glucose monitoring system IVD, home-use
Model / Reference
G-427B, G-425-2
Primary DI / UDI-DI
06939184631530, 06939184642529
Basic UDI-DI
6939184630001BD, B-06939184642529
Direct Marketing DI
06939184631530
510(k) Number
FDA Product Code
NBW
EMDN Code
W0201060102 Blood glucose meters
GMDN Term
Glucose monitoring system IVD, home-use
Device Class
Class C EUDAMED
Class IVD Annex II List B EUDAMED
Class II GUDID
Regulation Number
862.1345
EU market of registration
Malta
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
Class IVD Annex II List B
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000010625
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bioland Technology Ltd.

See all devices from Bioland Technology Ltd. →

Properties

  • Self Testing
  • Surgical Instrument
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No