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QSight 210 MD Screening System
EUDAMEDFDA UDIClass A (EU MDR)
Ref 2040-0010
by Wallac Oy
Identity
- Trade Name
- QSight 210 MD Screening System EUDAMEDFDA UDI
- Generic Name
- Mass spectrometry analyser IVD FDA UDI
- Device Name
- QSight 210 MD Screening System EUDAMED
- Model / Reference
- 2040-0010 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2040-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147371815 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147QSight_2104E EUDAMED
- FDA Product Code
- DOP FDA UDI
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Mass spectrometry analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2860 FDA UDI
- Market of Registration
- Finland 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
QSight 210 MD Screening System by Wallac Oy — 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 | 6438147QSight_2104E | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 97b6fd14-cd57-40a4-9002-c8bfca02ec45 61 fields · synced Jun 19, 2026
- FDA UDI 96b25480-b771-40e0-9abf-3c3ce17977b9 33 fields · synced May 29, 2026