← Back to catalogue
Glucocard S (gt-7110)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 109523Ref 109048Ref 109049Ref 100806Ref 108477Ref 104861Ref 101481Ref 100810Ref 101953Ref 109312Ref 100808
Identity
- Trade Name
- GLUCOCARD S (GT-7110) EUDAMED
- Device Name
- GLUCOCARD S (GT-7110) EUDAMED
- Model / Reference
- 109523 EUDAMED109048 EUDAMED109049 EUDAMED100806 EUDAMED108477 EUDAMED104861 EUDAMED101481 EUDAMED100810 EUDAMED101953 EUDAMED109312 EUDAMED100808 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109523N8 EUDAMEDD-109048MX EUDAMEDD-109049MZ EUDAMEDD-100806LQ EUDAMEDD-108477NK EUDAMEDD-104861MU EUDAMEDD-101481LR EUDAMEDD-100810LF EUDAMEDD-101953MD EUDAMEDD-109312MR EUDAMEDD-100808LU EUDAMED
- Basic UDI-DI
- B-109523N8 EUDAMEDB-109048MX EUDAMEDB-109049MZ EUDAMEDB-100806LQ EUDAMEDB-108477NK EUDAMEDB-104861MU EUDAMEDB-101481LR EUDAMEDB-100810LF EUDAMEDB-101953MD EUDAMEDB-109312MR EUDAMEDB-100808LU EUDAMED
- EMDN Code
- W0101060101,W0201060102 EUDAMEDW0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland EUDAMEDSpain EUDAMEDCroatia EUDAMEDFrance EUDAMEDLithuania 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 S (gt-7110) 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-109523N8 | 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 (11)
- EUDAMED b4b58a18-f263-4c9b-bdb2-6c511301ed30 61 fields · synced Sep 17, 2026
- EUDAMED 955ae660-e227-436c-b2d1-a71162d53468 61 fields · synced May 17, 2026
- EUDAMED 3e69a224-40b5-49fa-9584-1e145b299f47 61 fields · synced May 17, 2026
- EUDAMED 61a91ff2-ca7b-487b-96b3-cf5ca0d4f58c 61 fields · synced May 17, 2026
- EUDAMED 110d103c-a684-4334-98bd-7260becef08b 61 fields · synced May 17, 2026
- EUDAMED 7d44add8-a5d8-4ecd-aade-28a0d71d301c 61 fields · synced May 17, 2026
- EUDAMED 5b7e4825-7a8f-442e-b3c1-23875525cfaf 61 fields · synced May 17, 2026
- EUDAMED a3fe39b1-0141-437c-bcf5-ed967b030cb1 61 fields · synced May 18, 2026
- EUDAMED 874089aa-4fcc-465d-9648-7b377c6a3f7d 61 fields · synced May 18, 2026
- EUDAMED 9239fdc3-2c90-404d-9adf-27e7318009ca 61 fields · synced May 18, 2026
- EUDAMED beda95a2-d608-4139-a1d3-425512ccc2ed 61 fields · synced May 18, 2026