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GLUCOCARD X-sensor

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref 78726Ref 78723Ref 78730Ref 78710Ref 78724

by ARKRAY Factory, Inc.

Identity

Trade Name
GLUCOCARD X-sensor EUDAMED
Device Name
GLUCOCARD X-sensor EUDAMED
Model / Reference
78726 EUDAMED
78723 EUDAMED
78730 EUDAMED
78710 EUDAMED
78724 EUDAMED

Identifiers

Primary DI / UDI-DI
D-78726K8 EUDAMED
D-78723K2 EUDAMED
D-78730JX EUDAMED
D-78710JR EUDAMED
D-78724K4 EUDAMED
Basic UDI-DI
B-78726K8 EUDAMED
B-78723K2 EUDAMED
B-78730JX EUDAMED
B-78710JR EUDAMED
B-78724K4 EUDAMED
EMDN Code
W0101060101 GLUCOSE TEST STRIPS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
Romania EUDAMED
Austria EUDAMED
Czechia EUDAMED
Finland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

GLUCOCARD X-sensor by ARKRAY Factory, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
ARKRAY Factory, Inc.
EUDAMED SRN
JP-MF-000003008
Authorised Representative
ARKRAY Europe, B.V. NL-AR-000002056

Sources (5)

  • EUDAMED 3e300496-ba62-40ab-9c4d-5dbe2fa8946b 61 fields · synced Aug 4, 2026
  • EUDAMED 64dab971-9428-47dc-96a9-f4881d6582f5 61 fields · synced May 17, 2026
  • EUDAMED 808b3387-110c-4425-9cf4-75957e5f59a9 61 fields · synced May 17, 2026
  • EUDAMED 9d1d3b73-160f-4151-ac1a-9312fe515418 61 fields · synced May 19, 2026
  • EUDAMED 4da038fa-8c8f-47ed-b7a1-1e3d4908a2e3 61 fields · synced May 19, 2026