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Blood glucose test strips

by Bioland Technology Ltd.

Ref G-427BS

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDD EUDAMED NumberB-06939184600178 Basic UDI-DI 06939184600178UDI-DIDate25 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06939184600178 UDI-DI Date20 Jan 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Blood glucose test strips EUDAMED
bioland GUDID
Generic Name
Glucose IVD, kit, electrometry
Model / Ref / Catalog
G-427BS, Bioland
Primary DI / UDI-DI
06939184600178
Basic UDI-DI
B-06939184600178
510(k) Number
FDA Product Code
NBW
EMDN Code
W0101060101 Glucose test strips
GMDN Term
Glucose IVD, kit, electrometry
Device Class
Class IVD Annex II List B 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
G-427BS
GUDID
Bioland
Device ClassEUDAMED
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

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

Other properties (17)

  • Sterile: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No