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NOVA Lite® IFA Pancreatic Islet Cell Positive Control
EUDAMEDClass B (EU MDR)
Ref 704005
Identity
- Trade Name
- NOVA Lite® IFA Pancreatic Islet Cell Positive Control EUDAMED
- Device Name
- NOVA Lite® IFA Pancreatic Islet Cell Positive Control EUDAMED
- Model / Reference
- 704005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195126001038 EUDAMED
- Basic UDI-DI
- 842695059403195 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Yes
EUDAMED
NOVA Lite® IFA Pancreatic Islet Cell Positive Control by Inova Diagnostics, Inc. — Class B — 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 | 842695059403195 | Class B | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 5f12bbe6-e16a-49bc-84e9-fd2f6a11bf3c 61 fields · synced Jul 13, 2026