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GLUCOCARD X-mini plus (GT-1960)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 100477Ref 46708Ref 46744Ref 100475
Identity
- Trade Name
- GLUCOCARD X-mini plus (GT-1960) EUDAMED
- Device Name
- GLUCOCARD X-mini plus (GT-1960) EUDAMED
- Model / Reference
- 100477 EUDAMED46708 EUDAMED46744 EUDAMED100475 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100477LT EUDAMEDD-46708HP EUDAMEDD-46744HT EUDAMEDD-100475LP EUDAMED
- Basic UDI-DI
- B-100477LT EUDAMEDB-46708HP EUDAMEDB-46744HT EUDAMEDB-100475LP EUDAMED
- EMDN Code
- W0101060101,W0201060102 EUDAMEDW0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Austria EUDAMEDFinland EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GLUCOCARD X-mini plus (GT-1960) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-100477LT | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (4)
- EUDAMED dbceaa37-01ba-4d35-ab17-43b0b8f62f2a 61 fields · synced Jul 28, 2026
- EUDAMED 479c4dc6-b0f0-45f4-9f13-a89d161674a8 61 fields · synced May 16, 2026
- EUDAMED 7e5afa39-4ef5-4b6f-b7cf-c4930ba16ca7 61 fields · synced May 17, 2026
- EUDAMED 39058565-93b0-462e-84c1-f5a555b03ddf 61 fields · synced May 18, 2026