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Sign in to claim this brandELI LILLY AND COMPANY
US
Last updated May 24, 2026
What ELI LILLY AND COMPANY makes
The company produces mobile applications for medication reminders and patient-reported symptom tracking, mechanical empty self-injectors for drug delivery, single-use hypodermic needles, home-use glucose monitoring systems, and modular data memory units for patient monitoring systems. Convenience kits for injectable medications and prefilled pen devices for insulin delivery are also part of the portfolio.
These devices are regulated under FDA Class I and Class II classifications, with some requiring 510(k) clearance and others listed under the FDA’s Unique Device Identifier (UDI) system. The company’s products are based in the United States and appear in relevant FDA registries for medical device authorisation.
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 Eli Lilly and Company manufacture?
Eli Lilly and Company produces a range of medical devices including mobile applications for medication reminders and patient-reported symptoms, mechanical empty self-injectors for drug delivery, single-use hypodermic needles, home-use glucose monitoring systems, and modular data memory units for patient monitoring systems. Their portfolio also includes convenience kits for injectable medications and prefilled insulin delivery pens. These devices span both software-based solutions and physical medical hardware.
Where is Eli Lilly and Company based, and how does that affect its medical devices?
Eli Lilly and Company is based in the United States. Since the company operates under FDA regulations, its devices are subject to U.S. medical device classification and authorisation processes. This includes compliance with FDA requirements for Class I and Class II devices, as well as registration in relevant FDA databases like the 510(k) clearance system and the Unique Device Identifier (UDI) registry.
Which regulatory registries list Eli Lilly and Company’s medical devices?
Eli Lilly and Company’s medical devices are listed in the FDA’s 510(k) clearance registry for certain Class II devices requiring pre-market notification, as well as the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, helping to track authorised products through their lifecycle.
How are Eli Lilly and Company’s medical devices classified under FDA regulations?
Eli Lilly and Company’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and often require specific regulations or pre-market notifications like the 510(k) process. The classification determines the regulatory pathway each device must follow to achieve authorisation.
What role do convenience kits and prefilled pen devices play in Eli Lilly’s medical device portfolio?
Convenience kits and prefilled pen devices, such as those for injectable medications or insulin delivery, are designed to simplify administration for patients. These devices combine multiple components—like needles, syringes, or medication—into a single, ready-to-use system. While they may include mechanical or software elements (e.g., data memory modules), their primary purpose is to enhance usability and reduce errors in self-administered treatments, aligning with broader patient monitoring and medication adherence solutions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- 1-855-545-5983
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 006421325
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lilly Together | MA9161 Android (Version 15) | FDA UDI | Class I | Active |
| Lilly Together | MA9142 IOS (Version 17) | FDA UDI | Class I | Active |
| Tempo Welcome Kit | MS9841 | FDA UDI | Class II | Active |
| HumaPen® Luxura™ HD | MS9673 | FDA UDI | Class II | Active |
| Lilly Together | MA9158 IOS (Version 13) | FDA UDI | Class I | Active |
| ZYPREXA® Relprevv™ 300 mg Convenience Kit | VL7636 | FDA UDI | Class II | Active |
| Lilly Together | MA7723 IOS | FDA UDI | Class I | Active |
| Lilly Together | MA9140 IOS (Version 12) | FDA UDI | Class I | Active |
| ZYPREXA® Relprevv™ 405 mg Convenience Kit | VL7637 | FDA UDI | Class II | Active |
| HumatroPen® 12 mg | MS9561 | FDA UDI | Class II | Active |
| Lilly Together | MA9141 Android (Version 17) | FDA UDI | Class I | Active |
| ZYPREXA® Relprevv™ 210 mg Convenience Kit | VL7635 | FDA UDI | Class II | Active |
| Lilly Together | MA9131 Android | FDA UDI | Class I | Active |
| HumatroPen® 6 mg | MS9560 | FDA UDI | Class II | Active |
| Lilly Together | MA9160 IOS (Version 14) | FDA UDI | Class I | Active |
| Lilly Together | MA9135 ANDROID (Version 12) | FDA UDI | Class I | Active |
| HumaPen® Luxura™ HD - SAMPLE | MS9675 | FDA UDI | Class II | Active |
| Tempo Smart Button | MS6303 | FDA UDI | Class II | Active |
| Lilly Together | MA9162 IOS (Version 15) | FDA UDI | Class I | Active |
| Lilly Together | MA9152 Android (Version 13) | FDA UDI | Class I | Active |
| Tempo Refill Kit | MC0002 | FDA UDI | Class II | Active |
| Lilly Together | MA9159 Android (Version 14) | FDA UDI | Class I | Active |
| HumatroPen® 24 mg | MS9562 | FDA UDI | Class II | Active |
| Tempo Refill Kit | MS9599 | FDA UDI | Class II | Unknown |
| HumaPen Savvio | K160668 | FDA 510(k) | Class II | Active |
| HumanPen Ergo II | K151686 | FDA 510(k) | Class II | Active |
| Humapen And Humapen Ergo | K982842 | FDA 510(k) | Class II | Active |
| HumaPen Luxura | K142518 | FDA 510(k) | Class II | Active |
| Humapen Luxura Hd | K100988 | FDA 510(k) | Class II | Active |
| Go Dose System | K160949 | FDA 510(k) | Class II | Active |
| Humapen Luxura Hd | K063151 | FDA 510(k) | Class II | Active |
| Humapen Memoir | K053563 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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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.
Eli Lilly and Company has one FDA recall record initiated on March 17, 2011, which is marked as terminated. The recall pertains to alcohol prep pads supplied by the Triad Group, included in black starter kits for Forteo [teriparatide (rDNA origin) injection] in the United States, due to a potential issue as stated in the filing.
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 |
|---|---|---|---|---|
| Mar 17, 2011 | Z-2191-2011 | — | terminated | Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo [teriparatide (rDNA origin) injection] in the United States.The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infecti |