Skip to content

Glucose Control Solutions

by Bioland Technology Ltd. FDA registration: China EUDAMEDGUDID

Ref 803GCS003990 Product code NBWEMDN W010106010801

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberV74 051313 0032 Date17 Apr 2025IssuedStatusActive expires 16 Apr 2030
United StatesGUDID listing GUDID Number06939184600925 UDI-DIDate15 Feb 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Glucose Control Solutions EUDAMED
bioland GUDID
Generic Name
Glucose analyser IVD, home-use
Model / Reference
803GCS003990 EUDAMED
LEVEL 3 GUDID
Primary DI / UDI-DI
06939184600925
Basic UDI-DI
6939184650001C3
Direct Marketing DI
06939184600925
510(k) Number
FDA Product Code
NBW
EMDN Code
W010106010801 Blood test strips controls
GMDN Term
Glucose analyser IVD, home-use
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1345
Market of Registration
Malta
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
803GCS003990
GUDID
LEVEL 3
Device ClassEUDAMED
Class C
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 & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Professional Testing
  • Over-the-Counter
  • Serial Number
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED fd5bad05-f8fc-4b77-a4ac-54d6b663de24 61 fields · synced 22 Oct 2026
  • FDA UDI 87017d3a-f7f7-475a-b23f-d2e542e6f1f6 34 fields · synced 30 May 2026