Respiree Pte, Ltd.
Active in EUDAMEDSingaporefrom SRN EUDAMED FDA SRN SG-MF-000033374
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Respiree Pte, Ltd. makes
Respiree Pte, Ltd. manufactures the Respiree Cardio-Respiratory Monitor System and the Respiree Cardio-Respiratory Monitor, which are designed to continuously monitor heart and respiratory function for clinical use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Respiree Cardio-respiratory Monitor Ref RS001
Regimes: CE MDR Registry: EUDAMEDRespiree 1BioAI-Acute Ref RS001.1BioAI-Acute
Regimes: CE MDR Registry: EUDAMEDRespiree Cardio- Respiratory Monitor System Ref K250934
Regimes: CE MDR 510(k) Registry: 510(k)Respiree Cardio-Respiratory Monitor Ref K223681
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- SG-MF-000033374
- EUDAMED status
- Active
- EUDAMED registered name
- Respiree Pte Ltd
- Registered address
- 23 Cantonment Road, Singapore 089743, 089743, Singapore, Singapore
- [email protected]
- PRRC contact
- Daniel Yap
FDA establishments
- Respiree Pte Ltd Singapore Central Singapore · SG FEI 3020277584
Frequently asked questions
How many devices does Respiree Pte, Ltd. have in the registry?
The registry currently lists 4 devices for Respiree Pte, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Respiree Pte, Ltd.'s devices?
Among its 4 most recently registered devices, Respiree Pte, Ltd. has devices listed in EUDAMED (2 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Respiree Pte, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Respiree 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 Respiree Pte, Ltd. in the registry?
The most recently registered devices listed for Respiree Pte, Ltd. include Respiree Cardio-respiratory Monitor, Respiree 1BioAI-Acute and Respiree Cardio- Respiratory Monitor System.
Which FDA establishments are linked to Respiree Pte, Ltd.?
1 FDA establishment is linked to Respiree Pte, Ltd. in the registry; they are listed on the company page.