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Sign in to claim this brandROCHE DIABETES CARE, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 9115 Hague Road, Indianapolis, IN, 46250
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011393376
- DUNS Number
- —
Catalogue (77)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accu-Chek Fastclix | 09770526001 | FDA UDI | Class II | Active |
| Accu-Chek Fastclix | 05353815001 | FDA UDI | Class II | Active |
| Accu-Chek Softclix | 05181186001 | FDA UDI | Class II | Active |
| Accu-Chek Safe-T-Pro | 06372481160 | FDA UDI | Class II | Active |
| Accu-Chek Ultraflex | 04626591001 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 03144844001 | FDA UDI | Class II | Active |
| Accu-Chek Ultraflex | 04626613001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04541120001 | FDA UDI | Class II | Unknown |
| Accu-Chek Ultraflex | 04626648001 | FDA UDI | Class II | Unknown |
| Accu-Chek Coaguchek Softclix | 08120242001 | FDA UDI | Class II | Active |
| Accu-Chek Link Assist | 04530039001 | FDA UDI | Class II | Unknown |
| Accu-Chek Compact Plus | 05599415160 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 03146707119 | FDA UDI | Class II | Active |
| Accu-Chek Safe-T-Pro | 05888662160 | FDA UDI | Class II | Active |
| Accu-Chek Rapid-D Link | 04541081001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04541189001 | FDA UDI | Class II | Unknown |
| ACCU-CHEK Guide Blood Glucose Monitoring System | K160944 | FDA 510(k) | Class II | Active |
| Accu-Chek Ultraflex Infusion Set | K122686 | FDA 510(k) | Class II | Active |
| Accu-Chek Safe-T-Pro Uno Lancing Device | K220364 | FDA 510(k) | Class II | Active |
| ACCU-CHEK Connect Diabetes Management App | K150910 | FDA 510(k) | Class II | Active |
| IWL2020 Blood Glucose Monitoring System | K203711 | FDA 510(k) | Class II | Active |
| Accu-Chek Softclix Blood Lancing System | K214022 | FDA 510(k) | Class II | Active |
| Accu-Chek FastClix Blood Lancing System | K220608 | FDA 510(k) | Class II | Active |
| Accu-Chek Guide Me Blood Glucose Monitoring System | K181131 | FDA 510(k) | Class II | Active |
| Accu-Chek Safe-T-Pro Plus Lancing Device | K220849 | FDA 510(k) | Class II | Active |
| Accu-Chek Safe-T-Pro Uno Lancing Device | K232509 | FDA 510(k) | Class II | Active |
| Accu-Chek Safe-T-Pro Plus Lancing Device | K232488 | FDA 510(k) | Class II | Active |
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