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Sign in to claim this brandCOMPANION MEDICAL, INC.
US
Last updated May 30, 2026
What COMPANION MEDICAL, INC. makes
Companion Medical, Inc. manufactures mechanical empty self-injectors designed for insulin delivery, including systems with smart features for dose calculation and tracking. Their portfolio includes insulin pen devices with integrated technology to assist users in managing diabetes, such as automated dose reminders and connectivity options.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) and Unique Device Identifier (UDI) processes. The company’s products are listed in the FDA’s regulatory databases, and the manufacturer 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 medical devices does Companion Medical, Inc. manufacture?
Companion Medical, Inc. specializes in mechanical empty self-injectors, specifically designed for insulin delivery. Their devices include insulin pen systems with smart features, such as automated dose calculation and tracking tools, to help users manage diabetes more effectively. These products are tailored for users who require precise insulin dosing assistance.
Where is Companion Medical, Inc. based?
Companion Medical, Inc. is headquartered in the United States. The company’s location influences its regulatory compliance with U.S. medical device standards, including those set by the FDA.
Which regulatory registries or databases list Companion Medical, Inc.’s devices?
Companion Medical, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.
How are Companion Medical, Inc.’s insulin delivery devices classified under FDA regulations?
Companion Medical, Inc.’s insulin delivery devices fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- companion-medical.com
- —
- —
- [email protected]
- Phone
- 858-522-0252
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 057594435
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InPen Smart Insulin Delivery System | Novo - Pink | FDA UDI | Class II | Active |
| inpen™ | MMT-105EVNNWW | FDA UDI | Class II | Active |
| InPen Smart Insulin Delivery System | Lilly - Blue | FDA UDI | Class II | Active |
| inpen™ | MMT-105EVELWW | FDA UDI | Class II | Active |
| InPen Smart Insulin Delivery System | Novo - Blue | FDA UDI | Class II | Active |
| InPen Smart Insulin System | Novo - Grey | FDA UDI | Class II | Active |
| InPen Smart Insulin Delivery System | Lilly - Pink | FDA UDI | Class II | Active |
| InPen Smart Insulin Delivery System | Lilly - Grey | FDA UDI | Class II | Active |
| InPen System | K192841 | FDA 510(k) | Class II | Active |
| InPen | K160629 | FDA 510(k) | Class II | Active |
| InPen Dose Calculator | K181327 | FDA 510(k) | Class II | Active |
| InPen System | K201337 | FDA 510(k) | Class II | Active |
| InPen Dose Calculator | K190487 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Companion Medical, Inc. has one FDA recall record initiated on 2022-11-08, with the status recorded as both open and classified. The recall pertains to a diabetes management app that may experience crashes upon opening, during use, or while running in the background, potentially preventing users from accessing the app. The reported issue includes instances where an error message indicates the app has stopped or is unresponsive.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 8, 2022 | Z-0741-2023 | — | open, classified | Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia. |