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Glucocard W (gt-7210)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 100816Ref 108479Ref 109313Ref 100818Ref 109512Ref 109314Ref 108478Ref 100819
Identity
- Trade Name
- GLUCOCARD W (GT-7210) EUDAMED
- Device Name
- GLUCOCARD W (GT-7210) EUDAMED
- Model / Reference
- 100816 EUDAMED108479 EUDAMED109313 EUDAMED100818 EUDAMED109512 EUDAMED109314 EUDAMED108478 EUDAMED100819 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100816LT EUDAMEDD-108479NP EUDAMEDD-109313MT EUDAMEDD-100818LX EUDAMEDD-109512N3 EUDAMEDD-109314MV EUDAMEDD-108478NM EUDAMEDD-100819LZ EUDAMED
- Basic UDI-DI
- B-100816LT EUDAMEDB-108479NP EUDAMEDB-109313MT EUDAMEDB-100818LX EUDAMEDB-109512N3 EUDAMEDB-109314MV EUDAMEDB-108478NM EUDAMEDB-100819LZ EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Glucocard W (gt-7210) 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-100816LT | 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 (8)
- EUDAMED eacefd22-ed72-4f89-bf52-ce90a5f3b976 61 fields · synced Jul 23, 2026
- EUDAMED e7493e06-1050-443a-9a3f-9cb67ba01d4a 61 fields · synced May 17, 2026
- EUDAMED 25d74671-1077-41ba-a92a-5781f48ea124 61 fields · synced May 17, 2026
- EUDAMED dbdacb0b-72b3-443b-9772-ac674ab329a6 61 fields · synced May 17, 2026
- EUDAMED e5664c42-3e17-4464-898e-3a23000c9e00 61 fields · synced May 17, 2026
- EUDAMED a5d0ca37-ef44-4e3c-8a73-4b6f1ca8ed88 61 fields · synced May 18, 2026
- EUDAMED 710d0f0b-ffd5-4830-8fef-82aa906a6d5a 61 fields · synced May 19, 2026
- EUDAMED a1c9a471-dbfc-4dc0-a363-3e3d2dde2a0b 61 fields · synced May 19, 2026