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Sign in to claim this brandSibel Health Inc.
United States·US-MF-000037280
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2017, North Mendell St, Chicago, United States
- Website
- www.sibelhealth.com/
- —
- —
- [email protected]
- Phone
- +1 224-251-8859
- PRRC Contact
- Kevin Dwyer
- EUDAMED SRN
- US-MF-000037280
- FDA FEI Number
- 3015529350
- DUNS Number
- 093772547
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ANNE One System | SA-004-01 | EUDAMED | Class IIb | Active |
| Anne Chest Adhesive, Standard Wear | 900-00037 | EUDAMED | Class IIb | Active |
| 1-Day ANNE Chest Adhesive Pouch | 900-00014 | FDA UDI | Class II | Active |
| ANNE Sleep | SA-008 | FDA UDI | Class II | Active |
| Sibel Spacelabs Trek Charger | 900-00046 | FDA UDI | Class II | Active |
| Sibel Spacelabs Trek Chest Patch | 900-00039 | FDA UDI | Class II | Active |
| ANNE Pediatric | SA-011 | FDA UDI | Class II | Active |
| ANNE Bedside Wireless Charger | 900-00008 | FDA UDI | Class II | Active |
| ANNE Chest | 810-00012 | FDA UDI | Class II | Active |
| Sibel Spacelabs Trek Tablet | 900-00043 | FDA UDI | Class II | Active |
| ANNE Chest Sensor | 810-00012 | FDA UDI | Class II | Active |
| ANNE Chest Sensor Kit | 900-00007 | EUDAMEDFDA UDI | Class II | Active |
| ANNE View Patient Monitor | 900-00012 | FDA UDI | Class II | Active |
| ANNE Limb Adhesive Shelf Box | 900-00011 | EUDAMEDFDA UDI | Class II | Active |
| ANNE Limb Sensor | 810-00013 | FDA UDI | Class II | Active |
| 7-Day ANNE Chest Adhesive Shelf Box | 900-00010 | FDA UDI | Class II | Active |
| Sibel Spacelabs Finger Patch Adhesive 3 day | 900-00042 | FDA UDI | Class II | Active |
| ANNE™ One | SA-002 | FDA UDI | Class II | Active |
| Central Hub CMS | 900-00013 | FDA UDI | Class II | Active |
| ANNE Limb Sensor Kit | 900-00003 | FDA UDI | Class II | Active |
| ANNE Limb | 810-00013 | FDA UDI | Class II | Active |
| Central Hub Speaker | 900-00004 | FDA UDI | Class II | Active |
| Sibel Spacelabs Trek Blood Pressure Cuff | 900-00045 | FDA UDI | Class II | Active |
| Sibel Spacelabs Trek Finger Patch | 900-00041 | FDA UDI | Class II | Active |
| 7-Day ANNE Chest Adhesive Pouch | 900-00038 | FDA UDI | Class II | Active |
| Sibel Spacelabs Trek Chest Patch Adhesive | 900-00062 | FDA UDI | Class II | Active |
| ANNE Chest | K240251 | FDA 510(k) | Class II | Active |
| ANNE View, Central Hub | K242842 | FDA 510(k) | Class II | Active |
| ANNE Maternal | K253021 | FDA 510(k) | Class II | Active |
| ANNE Limb | K240305 | FDA 510(k) | Class II | Active |
| ANNE One | K223711 | FDA 510(k) | Class II | Active |
| Adam | SA-020 | EUDAMED | Class I | Active |
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