Identity
- Trade Name
- Aptiva® Multi-Analyte Instrument EUDAMEDAptiva® Multi-Analyte Instrument FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- Aptiva® Multi-Analyte Instrument EUDAMEDAptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The system is based on digital capture of high-resolution images of the paramagnetic particles to determine the analytes in samples FDA UDI
- Model / Reference
- AP5000 EUDAMEDFDA UDI
- Description
- Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The system is based on digital capture of high-resolution images of the paramagnetic particles to determine the analytes in samples FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426951307227 EUDAMEDFDA UDI
- Basic UDI-DI
- 84269513072276Z EUDAMED
- Direct Marketing DI
- 08426951307227 EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Multiplex analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aptiva® Multi-Analyte Instrument 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 | 84269513072276Z | 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 adb443ea-9e9d-4911-b35d-275846a8dc19 61 fields · synced Jun 19, 2026
- FDA UDI dc82f454-8d1c-4138-8ee4-37ea5f1e89e3 34 fields · synced May 30, 2026