Identity
- Trade Name
- Veya Dx 9 EUDAMEDFDA UDI
- Generic Name
- Pipetting system IVD FDA UDI
- Device Name
- configurable liquid handling workstation FDA UDI
- Model / Reference
- Veya Dx EUDAMED30246218 EUDAMEDVeya Dx 9 FDA UDI
- Description
- configurable liquid handling workstation FDA UDI
Identifiers
- Catalog Number
- 30246218 FDA UDI
- Primary DI / UDI-DI
- 07640137480295 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013748IVS10080000AEC EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pipetting system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Market of Registration
- Germany 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
Veya Dx 9 by Tecan Schweiz AG — 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 | 764013748IVS10080000AEC | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tecan Schweiz AG
- EUDAMED SRN
- CH-MF-000044877
- Authorised Representative
- Tecan Austria GmbH AT-AR-000044488
Sources (2)
- EUDAMED ec5f10b0-37f7-4c8a-8644-7ce10f91feb6 61 fields · synced Jul 9, 2026
- FDA UDI 6c16434d-04c2-4e4c-8b98-b56df4f0fb8c 35 fields · synced May 30, 2026