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Sign in to claim this brandAuris Health, Inc.
United States·US-MF-000017049
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 5490, Great America Parkway, Santa Clara, United States
- Website
- its.jnj.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Angelina Johonnot
- EUDAMED SRN
- US-MF-000017049
- FDA FEI Number
- 3023460764
- DUNS Number
- 015823456
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aspirating Biopsy Needle | MBR-000012 | FDA UDI | Class II | Active |
| Monarch™ Software Tower v2.1.2 | Version 2.1.2 | FDA UDI | Class II | Active |
| Monarch Endoscopy Controller | MON-000712 | FDA UDI | Class II | Active |
| Monarch Advanced Imaging Accessory Kit | MON-000709 | FDA UDI | Class II | Active |
| Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 | Version 2.2.5 | FDA UDI | Class II | Active |
| Monarch Bronchscope 2.0/Monarch Platform (P2) | MON-000006 | FDA UDI | Class II | Active |
| Monarch Platform, Bronchoscopy 4.1 | MON-000008 | FDA UDI | Class II | Active |
| Monarch™ Laptop P16 Software v4.1.0 | Version 4.1.0 | FDA UDI | Class II | Active |
| Monarch™ Software Laptop v2.1.3 | Version 2.1.3 | FDA UDI | Class II | Active |
| Monarch Endoscopy Platform (P1) Tower Upgrade | MON-000005-01 | FDA UDI | Class II | Unknown |
| Monarch Software Tower v2.2.1 | Version 2.2.1 | FDA UDI | Class II | Active |
| Monarch™ Software Tower v2.1.3 | Version 2.1.3 | FDA UDI | Class II | Active |
| Monarch Bronchoscope | MBR-000211-A | FDA UDI | Class II | Active |
| Monarch™ Software Laptop v2.1.2 | Version 2.1.2 | FDA UDI | Class II | Active |
| Monarch Software Cart v2.2.1 | Version 2.2.1 | FDA UDI | Class II | Active |
| Monarch Bronchoscope | MBR-000211-A | FDA UDI | Class II | Unknown |
| Bronchoscope Fluidics Tubing | MBR-000218 | FDA UDI | Class II | Active |
| Monarch Bronchscope 2.0/Monarch Platform (P2) | MON-000006 | FDA UDI | Class II | Active |
| Navigation Patient Patches | MBR-000016 | FDA UDI | Class II | Active |
| Extended Patient Introducer Mount | MON-000713 | FDA UDI | Class II | Active |
| Bronchoscope Fluidics Tubing | MBR-000018 | FDA UDI | Class II | Active |
| Monarch Endoscopy Platform (P1) System, Refurbished | MON-000005-01R | FDA UDI | Class II | Active |
| Monarch Software Cart v2.1.6 | Version 2.1.6 | FDA UDI | Class II | Active |
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