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Glucose Control Solutions

by Bioland Technology Ltd. 3 variants

Ref 803GCS001990

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

CE IVDR

Valid until

16 Apr 2030

CE IVDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberV74 051313 0032 Date17 Apr 2025IssuedStatusActive expires 16 Apr 2030
United StatesGUDID listing GUDID Number06939184600901 UDI-DI Date15 Feb 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Glucose Control Solutions EUDAMED
bioland GUDID
Generic Name
Glucose analyser IVD, home-use
Model / Reference
803GCS001990 EUDAMED
LEVEL 1 GUDID
Primary DI / UDI-DI
06939184600901
Basic UDI-DI
6939184650001C3
Direct Marketing DI
06939184600901
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
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
803GCS001990
GUDID
LEVEL 1
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

  • 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