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familyDr.™ Blood Glucose Monitoring System

by All Medicus Co., Ltd.

Ref AGM-513S-K2-S1Model AGM-513S

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88061283AGM513SKJF Basic UDI-DI 08806128351084UDI-DIDate23 Jul 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
AGM-513S Blood Glucose Monitoring System
Model / Reference
AGM-513S, AGM-513S-K2-S1
Primary DI / UDI-DI
08806128351084
Basic UDI-DI
88061283AGM513SKJF
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000020833
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • New Device: No