Identity
- Trade Name
- Aptiva® System Rinse EUDAMEDAptiva® System Rinse FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Aptiva® System Rinse EUDAMEDThe Aptiva System Rinse is intended for use on the Inova Diagnostics Aptiva Multi-Analyte Instrument. System Rinse is intended as a system fluid and predilution buffer on the Aptiva Multi-Analyte Instrument. FDA UDI
- Model / Reference
- AC1004 EUDAMEDFDA UDI
- Description
- The Aptiva System Rinse is intended for use on the Inova Diagnostics Aptiva Multi-Analyte Instrument. System Rinse is intended as a system fluid and predilution buffer on the Aptiva Multi-Analyte Instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793041157 EUDAMEDFDA UDI
- Basic UDI-DI
- 84307930411573H EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Buffered wash solution IVD 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aptiva® System Rinse 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 | 84307930411573H | 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 c2813a0b-63a8-45ef-a7fc-27197b7c5a23 61 fields · synced Jun 19, 2026
- FDA UDI 059b4372-9dd7-4b8c-b908-bfcd9b2fcb61 35 fields · synced May 30, 2026