Identity
- Trade Name
- NOVA View® AUTOLoader EUDAMEDFDA UDI
- Generic Name
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
- Device Name
- NOVA View® AUTOLoader EUDAMEDThe NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction. FDA UDI
- Model / Reference
- ADLR1000 EUDAMEDALDR1000 FDA UDI
- Description
- The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950643708 EUDAMEDFDA UDI
- Basic UDI-DI
- 84269506437088U EUDAMED
- FDA Product Code
- PIV FDA UDI
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.4750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NOVA View® AUTOLoader by Inova Diagnostics, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 84269506437088U | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED 0f1632f1-e9b2-4922-ae79-6f8a808aee58 61 fields · synced Jul 11, 2026
- FDA UDI 9d52307e-7f27-470a-97ef-a3d045ffed46 35 fields · synced May 30, 2026