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Sign in to claim this brandROCHE DIABETES CARE, INC.
US
Last updated September 17, 2026
What ROCHE DIABETES CARE, INC. makes
Roche Diabetes Care, Inc. manufactures blood lancing device tips, manual reusable blood lancing devices, and medical equipment clinical data interfacing software. Specific products include the Accu-Chek Fastclix, Accu-Chek Safe-T-Pro, and Accu-Chek Softclix lancing devices, as well as the Accu-Chek Coaguchek Softclix system.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. Roche Diabetes Care, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of products does Roche Diabetes Care, Inc. manufacture?
Roche Diabetes Care, Inc. manufactures blood lancing device tips, manual reusable blood lancing devices, and medical equipment clinical data interfacing software, based solely on the device categories and examples provided in the source data.
Where is Roche Diabetes Care, Inc. based?
Roche Diabetes Care, Inc. is based in the United States, as explicitly stated in the country field and confirmed in the summary section of the provided device data.
In which regulatory registries are Roche Diabetes Care, Inc.'s devices listed?
Roche Diabetes Care, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as directly specified in the LISTED IN field of the device data.
How are Roche Diabetes Care, Inc.'s devices classified under regulatory frameworks?
Roche Diabetes Care, Inc.'s devices are classified as Class I and Class II medical devices, as stated in the DEVICE CLASSES field, with no implication of company-wide approval or certification.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 9115 Hague Road, Indianapolis, IN, 46250
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3011393376
- DUNS Number
- —
Catalogue (77)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accu-Chek Combo | 07870434001 | FDA UDI | Class II | Unknown |
| Accu-Chek Spirit Cartridge | 04949935001 | FDA UDI | Class II | Unknown |
| Accu-Chek Fastclix | 05353807001 | FDA UDI | Class II | Active |
| Accu-Chek Safe-T-Pro | 03448622001 | FDA UDI | Class II | Active |
| Accu-Chek Rapid-D | 04541138001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04541090001 | FDA UDI | Class II | Unknown |
| Accu-Chek Safe-T-Pro | 03450074001 | FDA UDI | Class II | Active |
| Accu-Chek Combo | 05027250001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04541111001 | FDA UDI | Class II | Unknown |
| Accu-Chek Coaguchek Softclix | 06979009001 | FDA UDI | Class II | Active |
| Accu-Chek Ultraflex | 06593976001 | FDA UDI | Class II | Unknown |
| Accu-Chek Safe-T-Pro | 08029016160 | FDA UDI | Class II | Active |
| Accu-Chek Softclix | 11893238160 | FDA UDI | Class II | Active |
| Accu-Chek Compact Plus | 05888948160 | FDA UDI | Class II | Unknown |
| Accu-Chek Coaguchek Softclix | 08015333001 | FDA UDI | Class II | Active |
| Accu-Chek Softclix | 09275371001 | FDA UDI | Class II | Active |
| Accu-Chek Spirit Cartridge | 05206073001 | FDA UDI | Class II | Unknown |
| Accu-Chek Combo | 05458544001 | FDA UDI | Class II | Unknown |
| Accu-Chek Ultraflex | 04626583001 | FDA UDI | Class II | Unknown |
| Accu-Chek Fastclix | 07531567160 | FDA UDI | Class II | Active |
| Accu-Chek Ultraflex | 04626621001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04925769001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D Link | 04541065001 | FDA UDI | Class II | Unknown |
| Accu-Chek Ultraflex | 06593968001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04541162001 | FDA UDI | Class II | Unknown |
| Accu-Chek Ultraflex | 04626605001 | FDA UDI | Class II | Unknown |
| Accu-Chek Coaguchek Softclix | 07313462001 | FDA UDI | Class II | Active |
| Accu-Chek Rapid-D Link | 04541057001 | FDA UDI | Class II | Unknown |
| Accu-Chek Fastclix | 05360145001 | FDA UDI | Class II | Active |
| Accu-Chek Rapid-D | 04541103001 | FDA UDI | Class II | Unknown |
| Accu-Chek Rapid-D | 04541146001 | FDA UDI | Class II | Unknown |
| Accu-Chek Fastclix | 05864666160 | FDA UDI | Class II | Active |
| Accu-Chek Fastclix | 07523211001 | FDA UDI | Class II | Active |
| Accu-Chek Rapid-D | 04541154001 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 05509661001 | FDA UDI | Class II | Active |
| Accu-Chek Rapid-D Link | 04541073001 | FDA UDI | Class II | Unknown |
| Accu-Chek Compact Plus | 05919967160 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 03789721001 | FDA UDI | Class II | Active |
| Accu-Chek Combo | 05391512001 | FDA UDI | Class II | Unknown |
| Accu-Chek Ultraflex | 06593984001 | FDA UDI | Class II | Unknown |
| Accu-Chek Compact Plus | 05919983160 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 04980263001 | FDA UDI | Class II | Active |
| Accu-Chek Ultraflex | 06594000001 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 03146693119 | FDA UDI | Class II | Active |
| Accu-Chek Care | 10095946001 | FDA UDI | Class I | Active |
| Accu-Chek Ultraflex | 04847423001 | FDA UDI | Class II | Unknown |
| Accu-Chek Safe-T-Pro | 03740838001 | FDA UDI | Class II | Active |
| Accu-Chek Compact Plus | 05599423160 | FDA UDI | Class II | Unknown |
| Accu-Chek Combo | 05458382001 | FDA UDI | Class II | Unknown |
| Accu-Chek Fastclix | 05360188001 | FDA UDI | Class II | Active |
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