Healthstats International Pte Ltd
Inactive in EUDAMED since 2025Singaporefrom SRN EUDAMED SRN SG-MF-000025200
Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.
- Devices
- 19
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- MDSS GmbHDE
What Healthstats International Pte Ltd makes
HealthStats International Pte Ltd manufactures ambulatory blood pressure monitoring systems, including standalone devices like the BPro BT and BPro Evo, as well as integrated solutions combining hardware (e.g., A-Pulse CASPRO T7100/T7200) with dedicated PC software for data analysis (e.g., BProSoft CASP or MY-BP). The portfolio also includes calibration tools such as the BPCALIBRATOR MC3000/MC3100 and arterial pulse waveform analysis systems paired with software for cardiovascular monitoring. These devices are designed for continuous or ambulatory blood pressure and pulse waveform assessment in clinical and home settings.
The company’s devices fall under EU Class II and Class IIa classifications, with relevant products listed in the EUDAMED database and cleared via FDA’s 510(k) pathway in the United States. The manufacturer is based in Singapore and adheres to regulatory requirements for medical devices in both European and U.S. markets, ensuring compliance with applicable standards for diagnostic and monitoring systems.
Catalogue
Search and filter all 19 devicesCompany details
- EUDAMED SRN
- SG-MF-000025200
- DUNS number
- 628476459
- EUDAMED status
- Inactive since 2025
- EUDAMED registered name
- Healthstats International Pte Ltd
- Registered address
- 82 Playfair Road, 368001, Singapore, Singapore
- Website
- www.healthstats.com/
- [email protected]
- Phone
- +6568583248
- PRRC contact
- Serene Chang
Frequently asked questions
How many devices does HEALTHSTATS INTERNATIONAL PTE LTD have in the registry?
The registry currently lists 19 devices for HEALTHSTATS INTERNATIONAL PTE LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list HEALTHSTATS INTERNATIONAL PTE LTD's devices?
Among its 19 most recently registered devices, HEALTHSTATS INTERNATIONAL PTE LTD has devices listed in EUDAMED (3 devices), FDA 510(k) (7 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do HEALTHSTATS INTERNATIONAL PTE LTD's devices fall under?
Among its 19 most recently registered devices, the classes recorded for HEALTHSTATS INTERNATIONAL PTE LTD's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from HEALTHSTATS INTERNATIONAL PTE LTD in the registry?
The most recently registered devices listed for HEALTHSTATS INTERNATIONAL PTE LTD include A-PULSE CASP® Pulse Wave Analysis System T6400 Series, MC3100™+ Oscillometric Blood Pressure Monitor T3100 Series, A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional) T7100 Series and A-PULSE CASPal®+ Central Aortic Systolic Pressure Monitoring Device T7200 Series.