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Sign in to claim this brandDAO HEALTH
US
Last updated May 25, 2026
What DAO HEALTH makes
The company produces reusable breast pump support kits and electric breast pumps, including models designed for home use. These devices are intended to assist with milk expression and storage for breastfeeding or donor milk collection.
The portfolio consists of Class II medical devices, authorised through FDA 510(k) and UDI listings. The company operates from the United States.
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 Dao Health manufacture?
Dao Health specialises in two primary categories of medical devices: reusable breast pump support kits and electric breast pumps. These devices are designed to help with milk expression and storage, supporting breastfeeding or donor milk collection. The company’s focus is on products that assist parents and healthcare providers in managing lactation needs.
Where is Dao Health based, and does that affect its regulatory approach?
Dao Health is based in the United States. Since the company operates within the US market, its devices are authorised through the FDA’s regulatory pathways, including 510(k) premarket notifications and Unique Device Identifier (UDI) listings. The US regulatory framework governs the classification, submission, and compliance requirements for these products.
How are Dao Health’s devices classified by regulatory authorities?
Dao Health’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices typically require a 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Dao Health’s devices?
Dao Health’s devices are listed in the FDA’s 510(k) database and the UDI (Unique Device Identifier) registry. These registries track authorised medical devices in the US, including their classification, submission history, and compliance status. The UDI system ensures traceability and transparency in the supply chain, while the 510(k) database documents the premarket clearance process for these products.
Why are Dao Health’s breast pumps classified as Class II rather than Class I?
The FDA categorises medical devices based on risk and intended use. Dao Health’s electric breast pumps and support kits are classified as Class II because they involve mechanical components and electrical systems that, while not high-risk, require additional controls to mitigate potential hazards (e.g., electrical safety, proper sterilisation for reusable parts, or performance consistency). Class II devices undergo stricter scrutiny than Class I (low-risk) but less than Class III (high-risk), necessitating a 510(k) submission to demonstrate compliance with regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 022187754
Catalogue (99)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Freemie | FG076 | FDA UDI | Class II | Active |
| Freemie | FG085 | FDA UDI | Class II | Active |
| Freemie | FG065 | FDA UDI | Class II | Active |
| Freemie | FG116 | FDA UDI | Class II | Active |
| Freemie | FG063 | FDA UDI | Class II | Active |
| Freemie | FG020 | FDA UDI | Class II | Unknown |
| Freemie | FG021 | FDA UDI | Class II | Unknown |
| Freemie | FG044 | FDA UDI | Class II | Unknown |
| Freemie | FG080 | FDA UDI | Class II | Active |
| Freemie | FG027 | FDA UDI | Class II | Unknown |
| Freemie | FG024 | FDA UDI | Class II | Unknown |
| Freemie | FG050 | FDA UDI | Class II | Unknown |
| Freemie | FG032 | FDA UDI | Class II | Unknown |
| Freemie | FG077 | FDA UDI | Class II | Active |
| NUK Co-branded Liberty Pump | FG078 | FDA UDI | Class II | Unknown |
| Freemie | FG094 | FDA UDI | Class II | Active |
| Freemie | FG123 | FDA UDI | Class II | Active |
| Freemie | FG043 | FDA UDI | Class II | Unknown |
| Freemie | FG029 | FDA UDI | Class II | Unknown |
| Freemie | FG084 | FDA UDI | Class II | Active |
| Freemie | FG095 | FDA UDI | Class II | Active |
| Freemie | FG114 | FDA UDI | Class II | Active |
| Freemie | FG061 | FDA UDI | Class II | Unknown |
| Freemie | FG069 | FDA UDI | Class II | Active |
| Freemie | FG049 | FDA UDI | Class II | Unknown |
| Freemie | FG045 | FDA UDI | Class II | Unknown |
| Freemie | FG092 | FDA UDI | Class II | Active |
| Freemie | FG026 | FDA UDI | Class II | Unknown |
| Freemie | FG074 | FDA UDI | Class II | Active |
| Freemie | FG071 | FDA UDI | Class II | Active |
| Freemie | FG054 | FDA UDI | Class II | Unknown |
| Freemie | FG067 | FDA UDI | Class II | Active |
| Freemie | FG126 | FDA UDI | Class II | Active |
| Freemie | FG056 | FDA UDI | Class II | Unknown |
| Freemie | FG119 | FDA UDI | Class II | Active |
| Freemie | FG072 | FDA UDI | Class II | Active |
| Freemie | FG107 | FDA UDI | Class II | Active |
| Freemie | FG109 | FDA UDI | Class II | Active |
| Freemie | FG087 | FDA UDI | Class II | Active |
| Freemie | FG120 | FDA UDI | Class II | Active |
| Freemie | FG064 | FDA UDI | Class II | Active |
| Freemie | FG058 | FDA UDI | Class II | Unknown |
| Freemie | FG091 | FDA UDI | Class II | Active |
| Freemie | FG089 | FDA UDI | Class II | Active |
| Freemie Freedom | FG031 | FDA UDI | Class II | Unknown |
| Freemie Freedom | FG017 | FDA UDI | Class II | Unknown |
| Freemie Breast Collection System | K130349 | FDA 510(k) | Class II | Active |
| Freemie (r) | K111411 | FDA 510(k) | Class II | Active |
| Freemie Independence, Freemie Liberty | K172772 | FDA 510(k) | Class II | Active |
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