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GLUCOCARD W Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 103710Ref 109516Ref 108486Ref 109514Ref 108482Ref 104952Ref 108485
Identity
- Trade Name
- GLUCOCARD W Test Strips EUDAMED
- Device Name
- GLUCOCARD W Test Strips EUDAMED
- Model / Reference
- 103710 EUDAMED109516 EUDAMED108486 EUDAMED109514 EUDAMED108482 EUDAMED104952 EUDAMED108485 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-103710LX EUDAMEDD-109516NB EUDAMEDD-108486NL EUDAMEDD-109514N7 EUDAMEDD-108482NC EUDAMEDD-104952MY EUDAMEDD-108485NJ EUDAMED
- Basic UDI-DI
- B-103710LX EUDAMEDB-109516NB EUDAMEDB-108486NL EUDAMEDB-109514N7 EUDAMEDB-108482NC EUDAMEDB-104952MY EUDAMEDB-108485NJ EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
EUDAMEDEUDAMED
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 W Test Strips 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-103710LX | 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 (7)
- EUDAMED cc8f4cb1-fa50-409d-a073-64537303dcff 61 fields · synced Jul 20, 2026
- EUDAMED e79a2351-4147-4167-a386-562bf6a780db 61 fields · synced May 18, 2026
- EUDAMED 0ffb2c34-d80b-4971-b898-bea7288b3c91 61 fields · synced May 18, 2026
- EUDAMED ba4d8447-ac85-4811-a322-16f1c36d7796 61 fields · synced May 18, 2026
- EUDAMED 18a72b48-aff7-494e-83fb-1e72cd272abf 61 fields · synced May 18, 2026
- EUDAMED 307eeff1-3bf9-41bd-9ff4-5beb465db24f 61 fields · synced May 18, 2026
- EUDAMED 829d118f-29ca-488f-b514-d2981f4ccf03 61 fields · synced May 19, 2026