CPAP machine
Resvent CPAP Made in China? What 5 Public Registers Show
Is the Resvent CPAP made in China? Yes. The Resvent iBreeze is made in China by Resvent Medical Technology Co., Ltd. in Shenzhen. Singapore's HSA register shows China as the place of manufacture for 11 of 11 iBreeze models, all Class B. In the US, the FDA cleared one Resvent model in July 2026, and our search of its recall database found no Resvent recalls.
First, who is telling you this. YesCPAP is a CPAP equipment seller in Singapore, and Jo Ng, who runs it, is a sleep technologist, not a doctor. We sell the iBreeze range ourselves, and on HSA's register our company, Yes CPAP (Private Limited), is the registrant for both Resvent records. So read this as a supplier showing you the public records. Every record number is given so you can check it yourself.
Key takeaways
- Who makes it: Resvent Medical Technology Co., Ltd., Shenzhen, China.
- Singapore: the iBreeze PAP System (DE0507383) has been on HSA's register since 17 October 2022, Class B, 11 models, all made in China.
- Same class as the big brand: ResMed's AirSense 10 and AirSense 11 are also Class B on the same register.
- United States: one 510(k) clearance (K253044, RXiBreeze 20C, 23 July 2026), no recalls found, 10 adverse-event reports that the FDA itself says cannot show cause.
- What to check: the exact model on HSA's register and who supports it locally, not the country on the box.
Who makes the Resvent iBreeze?
Resvent Medical Technology Co., Ltd. makes the iBreeze in Shenzhen, Guangdong. Its user manual names the company as manufacturer, with a factory address in Bao'an, Shenzhen, People's Republic of China. Singapore's register lists the product owner in Shenzhen, Guangdong.
On its own website, Resvent says it sells in more than 60 countries and regions, and lists China's NMPA, CE marking and an FDA emergency use authorisation (EUA) among its approvals. That is the company describing itself. We checked the US part against the FDA's own databases below. We did not check the EU records.
The manual lists the safety standards the CPAP is built to meet. IEC 60601-1 covers general safety for medical electrical equipment, IEC 60601-1-2 covers electromagnetic compatibility and IEC 60601-1-11 covers use in the home. ISO 80601-2-70 is the standard written specifically for sleep apnoea breathing therapy equipment.
The same manual (document H-4000-000002-00, version 5.0) states a useful service life of 10 years for the iBreeze 20C, 20C Pro, 20A and 20A Pro. Our guide to how long a CPAP machine lasts explains what that figure does and does not cover.
Is the Resvent iBreeze registered in Singapore?
Yes. HSA's Singapore Medical Device Register lists the Resvent iBreeze PAP System as DE0507383 and the Resvent RXiBreeze Plus CPAP System as DE0508520, both Class B, with Yes CPAP (Private Limited) as registrant.
Singapore's Health Sciences Authority keeps a public Singapore Medical Device Register, searchable from HSA's infosearch page. HSA sorts devices into four risk classes, from A (lowest) to D, and labels Class B as low-to-mid risk. Anything above Class A has to be registered with HSA before it can be sold. So a CPAP sold here should appear on that register by name.
A search for Resvent as product owner, run on 15 October 2026, returned two records:
| Record | Product name | Registered | Class | Registrant | Place of manufacture |
|---|---|---|---|---|---|
| DE0507383 | Resvent iBreeze PAP System, 11 models: 20A and 20A Pro, 20C and 20C Pro, 25A (BPAP), 25S, 25ST, 25STA, 30ST, 30STA and Tech | 17 October 2022 | Class B | Yes CPAP (Private Limited) | China for each of the 11 |
| DE0508520 | Resvent RXiBreeze Plus CPAP System | 25 September 2023 | Class B | Yes CPAP (Private Limited) | Not shown on the public page |
For comparison, the same register lists five ResMed AirSense records (AirSense 10 CPAP, AutoSet, AutoSet for Her, Elite, and AirSense 11), all Class B. In HSA's risk terms, the iBreeze and the AirSense sit in the same class.
The registered intended use for the iBreeze is positive airway pressure therapy for obstructive sleep apnoea in spontaneously breathing patients over 30 kg, at home, in hospital or in an institution. If you are weighing the two brands, our comparison of the iBreeze and the ResMed AirSense covers price and features.
Is the Resvent iBreeze FDA cleared?
One Resvent model is: the RXiBreeze 20C received FDA 510(k) clearance on 23 July 2026. That does not mean every iBreeze model sold in Singapore is FDA-cleared.
Resvent's site still describes its US status as an emergency use authorisation. The FDA's 510(k) database now has a full decision on file. Record K253044 covers the RXiBreeze PAP System (RXiBreeze 20C), and the applicant is Resvent's Shenzhen company. The FDA received it on 22 September 2025 and found it substantially equivalent on 23 July 2026. A search of that database for Resvent as applicant returns that one record.
Read the model name carefully. The cleared model carries a US name, RXiBreeze 20C. That clearance does not prove every iBreeze model sold in Singapore is FDA-cleared, and we do not claim it does. In Singapore, HSA registration is the approval that applies. Separately, the FDA lists Resvent as a registered establishment in China (FEI 3019793765).
We also queried the FDA's recall database for Resvent as recalling firm and for iBreeze in the product description. Both returned no records on 15 October 2026.
The FDA's adverse-event database (MAUDE) holds 10 reports naming Resvent, received between May 2022 and June 2025. The FDA warns that these reports can be incomplete or unverified, that they cannot show how often a problem happens, and that "a causal relationship cannot be established" from them. So a count of reports is not a reliability score in either direction.
Resvent CPAP made in China: does it matter?
The worry is reasonable. One buyer on a local forum put it plainly in June 2026: "If there are materials with toxic chemicals used in any part of the machine, you will be poisoning yourself every night." You breathe through this machine for hours, every night, for years.
Our view is that the country on the box answers the wrong question. What protects you is the record behind the exact unit you buy: whether that model is on HSA's register, which standards its manual says it meets, and whether a registrant in Singapore takes responsibility for it when there is a problem.
A brand-name machine from anywhere can still have a problem, as owners of recalled Philips DreamStation machines found out. Our article on keeping or replacing a Philips DreamStation covers that recall. An unbranded machine bought online may have no Singapore registration at all.
So the useful split is not China versus elsewhere. It is registered and supported versus unregistered and unsupported, and the iBreeze falls in the first group on the records above. We sell it, and our product page says we use it ourselves every night. That is exactly why we would rather you check the register than take our word for it. If you already own a machine that works and suits you, keeping it is a perfectly good choice.
How do you check a CPAP in Singapore before you buy?
- Start with your prescription. Your doctor decides whether you need CPAP or BiPAP and sets the pressure. Buy the machine after that, not before.
- Get the exact model name. It is on the label under the machine and in the manual, for example "iBreeze 20A".
- Search HSA's register. Open the Singapore Medical Device Register on HSA's infosearch page and type the brand into Product Owner or Product Name, or the record number into Product Number. Open the record and check that your model is listed.
- Read the registrant line. That is the Singapore company responsible for the registration. Ask the seller whether they are that company or buy through it.
- Check the manual for the standards. Look for ISO 80601-2-70 and IEC 60601-1. A machine without a proper manual is a warning in itself.
- Be careful with used or overseas units. Our guide to buying a used CPAP machine covers what to ask.
Talk it through before you buy
Jo works as a sleep technologist and is not a doctor. Your physician makes the diagnosis and sets your pressure. Once you have the prescription or your sleep study report, WhatsApp Jo on +65 9858 4461 with the model you are considering. Expect a chat about setup or mask fit. It is general guidance, never a diagnosis.
The Resvent iBreeze Auto CPAP is S$1,400 with a heated humidifier and heated tubing; the Pro is S$1,500, the Plus travel unit S$1,700 and the Auto BiPAP S$2,000. Our review of the Resvent iBreeze covers how it is to live with.
Method
On 15 October 2026 we searched HSA's Singapore Medical Device Register (Product Owner "Resvent"; Product Name "AirSense"), opened each record and copied every model row. Through the FDA's public API we queried its 510(k), recall, adverse-event and establishment databases. The standards and the service-life figure are taken from Resvent's own manual for the iBreeze (document H-4000-000002-00, version 5.0). Every row, with its source and date, is in the dataset below.
Limits
A register entry shows a device is listed for sale, not that it suits you. HSA's public page shows no model table for DE0508520. The FDA clearance covers a US-named variant. Adverse-event reports are unverified and do not show cause. We did not check EU records or where ResMed machines are made. Registers change: these results hold for 15 October 2026.
Cite this
YesCPAP (2026). Resvent CPAP Made in China? What 5 Public Registers Show. Register check dated 15 October 2026. The full table of register rows is published with this article: register check dataset (CSV).
This article is for general information only and is not medical advice, diagnosis or treatment. Sleep apnoea is diagnosed by a doctor after a sleep study, and CPAP therapy needs a doctor's prescription. Please speak to a qualified healthcare professional about your own situation.



