Monica Healthcare
United KingdomFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Monica Healthcare makes
Monica Healthcare manufactures continuous ambulatory blood pressure monitoring devices, including the AN24 and IF24 systems, as well as the NOVII Wireless Patch System for non-invasive, wearable blood pressure tracking.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Monica AN24 Ref K112390
Regimes: 510(k) Registry: 510(k)Monica IF24 Ref K112163
Regimes: 510(k) Registry: 510(k)Monica Novii Wireless Patch System Ref K140862
Regimes: 510(k) Registry: 510(k)Monica AN24 Ref K101801
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Monica Healthcare, initiated on 2017-04-28. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 28 Apr 2017 Z-2588-2017 Class II Terminated Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Full distribution text
- 28 Apr 2017 Z-2588-2017 Class II Terminated Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Frequently asked questions
How many devices does Monica Healthcare have in the registry?
The registry currently lists 9 devices for Monica Healthcare. Devices recorded under merged duplicate company entries are counted once.
Which registries list Monica Healthcare's devices?
Among its 9 most recently registered devices, Monica Healthcare has devices listed in FDA 510(k) (4 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Monica Healthcare's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Monica Healthcare's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Monica Healthcare?
FDA recall records list 1 recall initiated by Monica Healthcare, the most recent initiated on 28 Apr 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Monica Healthcare in the registry?
The most recently registered devices listed for Monica Healthcare include Novii 107-PT-020, Novii 107-PT-003, Novii 107-PT-002-US and Monica 105-PT-103.