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Sign in to claim this brandLutech Industries
United States·US-MF-000034764
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3910 Industrial Blvd, Indianapolis, United States
- Website
- www.lutechmedical.com
- —
- —
- [email protected]
- Phone
- 1 631 676 7432
- PRRC Contact
- Dean Honkonen
- EUDAMED SRN
- US-MF-000034764
- FDA FEI Number
- 3036423383
- DUNS Number
- —
Catalogue (114)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| Lutech | Datalys 760 | FDA UDI | Class II | Active |
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| Lutech | Datalys 750 | FDA UDI | Class II | Active |
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| Lutech | Datalys 760 | FDA UDI | Class II | Active |
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| Lutech | Datalys 780 | FDA UDI | Class II | Active |
| LT-300 Video Colposcope | K143119 | FDA 510(k) | Class II | Active |
| Datalys Multi-Parameter Patient Monitor | K150691 | FDA 510(k) | Class II | Active |
| LT-300 SD Digital Video Colposcope | K170446 | FDA 510(k) | Class II | Active |
| Digital Video Colposcope LT300HD | LT300 HD | EUDAMED | Class I | Active |
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