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Sign in to claim this brandBIOPTIGEN, INC.
US
Last updated May 27, 2026
Information
- Country
- US
- Address
- —
- Website
- leica-microsystems.com
- —
- —
- [email protected]
- Phone
- +1(847)8213502
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 361420040
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Enfocus 2300 Vhr 120v | 90-C2350-V2-120 | FDA UDI | Class II | Active |
| Enfocus 4400 Hr 120v | 90-C4450-H2-120 | FDA UDI | Class II | Active |
| Envisu C2300 Vhr 220v | 90-C2300-V1-220 | FDA UDI | Class II | Active |
| Envisu C2300 Vhr 100v | 90-C2300-V1-100 | FDA UDI | Class II | Active |
| Enfocus 2300 Vhr 100v | 90-C2350-V2-100 | FDA UDI | Class II | Active |
| Enfocus 4400 Hr 220v | 90-C4450-H2-220 | FDA UDI | Class II | Active |
| Enfocus 4400 Vhr 100v | 90-C4450-H2-100 | FDA UDI | Class II | Active |
| Enfocus 2300 Integrated Oct | 900C23550V5 | FDA UDI | Class II | Active |
| Enfocus 2300 Integrated Oct | 90-C2350-V4 | FDA UDI | Class II | Active |
| Enfocus 2300 Vhr 220v | 90-C2350-V2-220 | FDA UDI | Class II | Active |
| Envisu C2300 Vhr 120v | 90-C2300-V1-120 | FDA UDI | Class II | Active |
| Envisu Spectral Domain Ophthalmic Imaging System (sdois) | K120057 | FDA 510(k) | Class II | Active |
| Bioptigen Spectral Domain Ophthalmic Imaging System | K063343 | FDA 510(k) | Class II | Active |
| EnFocus 2300, EnFocus 4400 | K162783 | FDA 510(k) | Class II | Active |
| EnFocus 2300, EnFocus 4400 | K150722 | FDA 510(k) | Class II | Active |
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