← Back to catalogue
GLUCOCARD S Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 109217Ref 102632Ref 109219Ref 108502Ref 108503Ref 102633
Identity
- Trade Name
- GLUCOCARD S Control Solution EUDAMED
- Device Name
- GLUCOCARD S Control Solution EUDAMED
- Model / Reference
- 109217 EUDAMED102632 EUDAMED109219 EUDAMED108502 EUDAMED108503 EUDAMED102633 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109217MW EUDAMEDD-102632LV EUDAMEDD-109219N2 EUDAMEDD-108502MR EUDAMEDD-108503MT EUDAMEDD-102633LX EUDAMED
- Basic UDI-DI
- B-109217MW EUDAMEDB-102632LV EUDAMEDB-109219N2 EUDAMEDB-108502MR EUDAMEDB-108503MT EUDAMEDB-102633LX EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland EUDAMEDCroatia 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 S Control Solution 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-109217MW | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (6)
- EUDAMED 4030d088-b24f-4e9b-b7a4-ffd21d314285 61 fields · synced Aug 2, 2026
- EUDAMED 4fa0e4aa-5f0e-48b1-a055-f2b1a066e2bb 61 fields · synced May 18, 2026
- EUDAMED 2bb2cc29-62e6-4e5a-8beb-20fcfb2538c2 61 fields · synced May 18, 2026
- EUDAMED 8d898333-a275-484e-a27c-6e8fe8b8443d 61 fields · synced May 18, 2026
- EUDAMED 30cfd482-2ab8-4b49-afcf-6b55479d78d8 61 fields · synced May 18, 2026
- EUDAMED 86321312-3b99-4ecf-8bd5-edb3432434c0 61 fields · synced May 18, 2026