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GLUCOCARD W Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 108492Ref 108491Ref 108489Ref 108488Ref 103716Ref 103714Ref 108487Ref 103715
Identity
- Trade Name
- GLUCOCARD W Control Solution EUDAMED
- Device Name
- GLUCOCARD W Control Solution EUDAMED
- Model / Reference
- 108492 EUDAMED108491 EUDAMED108489 EUDAMED108488 EUDAMED103716 EUDAMED103714 EUDAMED108487 EUDAMED103715 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-108492NF EUDAMEDD-108491ND EUDAMEDD-108489NS EUDAMEDD-108488NQ EUDAMEDD-103716MB EUDAMEDD-103714M7 EUDAMEDD-108487NN EUDAMEDD-103715M9 EUDAMED
- Basic UDI-DI
- B-108492NF EUDAMEDB-108491ND EUDAMEDB-108489NS EUDAMEDB-108488NQ EUDAMEDB-103716MB EUDAMEDB-103714M7 EUDAMEDB-108487NN EUDAMEDB-103715M9 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS 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
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 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-108492NF | 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 a12911bc-0d8d-43bd-93de-3b27340cb97e 61 fields · synced Jul 25, 2026
- EUDAMED 22dfa5cf-f4fa-457a-b3f6-ef8993101be9 61 fields · synced May 16, 2026
- EUDAMED e525e595-cf93-4337-a844-dfdea3fa1b5e 61 fields · synced May 17, 2026
- EUDAMED 8534d226-362b-4423-aabf-060d8e139f9d 61 fields · synced May 18, 2026
- EUDAMED 7374142e-ba96-4480-aaf8-e705552f4262 61 fields · synced May 18, 2026
- EUDAMED 34c9d467-2ed5-45d5-976d-b2e3134c1e6f 61 fields · synced May 18, 2026
- EUDAMED 60b6b22b-c782-4e44-b1c0-8c3da2f7b0b5 61 fields · synced May 18, 2026
- EUDAMED 76c2ab1d-7fe4-4c38-a8b6-4b6c98a5bc61 61 fields · synced May 18, 2026