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Sign in to claim this brandBIOINTELLISENSE INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 17301 W. Colfax Ave., Golden, CO, 80401
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3017986070
- DUNS Number
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Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioButton v3 (BBN-r, different batch) | BIOST06040 | FDA UDI | Class II | Active |
| BioButton Adhesive V2 (ADH-CS) | ADH-CS-10771 | FDA UDI | Class I | Active |
| BioButton Charging Station | CRG-12685 | FDA UDI | Class II | Active |
| BioButton (In Bulk Packaging) | BIOST0604F v2.1 | FDA UDI | Class II | Active |
| BioButton (Reprocessed) | BBR-B-I-R | FDA UDI | Class II | Active |
| BioButton At-Home Kit with Power Adaptor and Adhesives | KIT-BBR-3763-5 | FDA UDI | Class II | Active |
| BioSticker™ | BIOST01021F | FDA UDI | Class II | Active |
| BioDashboard | SW-BDB | FDA UDI | Class II | Active |
| BioButton At-Home Kit with Power Adaptor | KIT-BBR-3763-1 | FDA UDI | Class II | Active |
| BioButton At-Home Kit with Adhesives and BioButton | KIT-BBR-3763-4 | FDA UDI | Class II | Active |
| BioButton v3 (BBN-r, different batch, Individual Pack) | BIOST06040 | FDA UDI | Class II | Active |
| BioButton | BIOST03020F | FDA UDI | Class II | Active |
| BioButton Rechargeable Device, Multi-Patient | BBRM-B-I-N | FDA UDI | Class II | Active |
| BioButton Rechargeable Adhesives (ADD-HT) | ADH-AC1-BBR-5-1-1-10 | FDA UDI | Class I | Active |
| BioButton v2 | BIOST05020F | FDA UDI | Class II | Active |
| BioButton (Reprocessed, NF Version) | BBR-B-I-R (BBR-B-NF-I-R) | FDA UDI | Class II | Active |
| BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton | KIT-BBR-3763-3 | FDA UDI | Class II | Active |
| BioSticker™ System Offload Software | SWDT10001-1.1.1 | FDA UDI | Class II | Active |
| BioButton v3 (BBN-r) | BIOST06040F | FDA UDI | Class II | Active |
| BioButton At-Home Kit | KIT-BBR-3763-2 | FDA UDI | Class II | Active |
| BioButton Rechargeable Adhesives | ACCS-1-ST06-1-4 | FDA UDI | Class I | Active |
| BioButton System | K241101 | FDA 510(k) | Class II | Active |
| BioSticker System | K191614 | FDA 510(k) | Class II | Active |
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