Haenim Co., Ltd.
South KoreaFDA applicant, unverified FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Haenim Co., Ltd. makes
Haenim Co., Ltd. makes medical devices such as powered breast pumps, including Models 7V and 7X.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Powered Breast Pump (Models 7V and 7X) Ref K211016
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 688864716
- [email protected]
- Phone
- 0323246614
FDA establishments
- Haenim CO., LTD. Seo-gu Incheon · KR FEI 3012119286
Frequently asked questions
How many devices does Haenim Co., Ltd. have in the registry?
The registry currently lists 9 devices for Haenim Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haenim Co., Ltd.'s devices?
Among its 9 most recently registered devices, Haenim Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Haenim Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Haenim Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haenim Co., Ltd. in the registry?
The most recently registered devices listed for Haenim Co., Ltd. include Haenim HN-7V-WH-GD, Haenim HN-7V-WH-MB, Haenim HN-7V-BK-GD and Haenim HN-7V-BK-MB.
Which FDA establishments are linked to Haenim Co., Ltd.?
1 FDA establishment is linked to Haenim Co., Ltd. in the registry; they are listed on the company page.