Identity
- Trade Name
- HYDROFLEX PLUS EUDAMEDFDA UDI
- Generic Name
- Microplate washer IVD FDA UDI
- Device Name
- HYDROFLEX PLUS EUDAMEDMicroplate washer FDA UDI
- Model / Reference
- 30190374 EUDAMED30190374 00 FDA UDI
- Description
- Microplate washer FDA UDI
Identifiers
- Catalog Number
- 30190374 FDA UDI
- Primary DI / UDI-DI
- 09120052071160 EUDAMEDFDA UDI
- Basic UDI-DI
- 912005207IVS10080001AP4 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W0201020299 LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER EUDAMED
- GMDN Term
- Microplate washer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Austria 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
Hydroflex Plus by Tecan Austria GmbH — 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 | 912005207IVS10080001AP4 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tecan Austria GmbH
- EUDAMED SRN
- AT-MF-000020241
Sources (2)
- EUDAMED 31e83f20-ebdc-4dc7-813a-e61a78a709b3 61 fields · synced Jul 16, 2026
- FDA UDI 583e7015-2406-4b03-8141-aa46c0cb2907 35 fields · synced May 30, 2026