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Gluten DQuick DResolution v4
EUDAMEDClass C (EU MDR)
Ref RT-59v4_96Model RT-59v4
by Clonit srl
Identity
- Trade Name
- Gluten DQuick DResolution v4 EUDAMED
- Device Name
- Gluten DQuick DResolution v4 EUDAMED
- Model / Reference
- RT-59v4 EUDAMEDRT-59v4_96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680910909 EUDAMED08057680910893 EUDAMED
- Basic UDI-DI
- 805768091GlutenDQ_02E3 EUDAMED
- EMDN Code
- W0106010401 HLA-TYPING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Gluten DQuick DResolution v4 by Clonit srl — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 805768091GlutenDQ_02E3 | Class C | Active |
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Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (2)
- EUDAMED 67222916-1967-4b24-b25a-11df5e5c59dc 61 fields · synced Jul 22, 2026
- EUDAMED 44e9228c-400f-42f9-9ef1-76b869a6026f 61 fields · synced May 16, 2026