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Gluten DQuick Dresolution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref RT-59v3
by Clonit srl
Identity
- Trade Name
- Gluten DQuick Dresolution EUDAMED
- Device Name
- Gluten DQuick DResolution EUDAMED
- Model / Reference
- RT-59v3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680910688 EUDAMED
- Basic UDI-DI
- B-08057680910688 EUDAMED
- EMDN Code
- W0106010401 HLA-TYPING EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
Gluten DQuick Dresolution by Clonit srl — 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-08057680910688 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (1)
- EUDAMED 78b12c36-c50a-4199-8ca3-8638eb16a63b 61 fields · synced Jun 18, 2026