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Sign in to claim this brandSpectral Medical Inc.
Canada·CA-MF-000007450
Last updated September 17, 2026
Information
- Country
- Canada
- Address
- 135, The West Mall, Toronto, Canada
- Website
- spectraldx.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Ennalisa Baker
- EUDAMED SRN
- CA-MF-000007450
- FDA FEI Number
- 3000058367
- DUNS Number
- —
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Endotoxin Activity Assay (EAA) | EAAST-20 | FDA UDI | Class II | Active |
| SAMI RRT Cassette | SA-400-00 | FDA UDI | Class II | Unknown |
| Endotoxin Activity Assay (EAA) | EAAST-NA | FDA UDI | Class II | Active |
| SAMI Hemofiltration Cassette | SM-200-003 | FDA UDI | Class II | Unknown |
| Sami Rrt | SM-100-003 | FDA UDI | Class II | Unknown |
| Smart Line TL Tube Luminometer | 84007 | FDA UDI | Class I | Active |
| Sirius 2 Tube Luminometer | 8401801 | EUDAMEDFDA UDI | Class A | Active |
| Endotoxin Activity Assay (EAA) | K183176 | FDA 510(k) | Class II | Active |
| SAM CRRT Unit, SAM Cassette CRRT | K170790 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
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