Edan Instruments, Inc.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000009957
Edan Instruments, Inc. is a medical device manufacturer based in China, with 695 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I, Class IIa and IVD General; FDA Class II) as of 14 Nov 2026.
- Devices
- 695
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 655
- FDA GUDID 244
- FDA 510(k) 45
- Device classes
- EU Class I 336
- EU Class IIa 167
- EU IVD General 65
- FDA Class II 43
- EU Class IIb 42
- EU Class A 28
- Top EMDN categories
- Sites and related companies
- Shanghai International Holding Corp. GmbH(Europe) authorised representative
- Identifiers
- EUDAMED SRN CN-MF-000009957
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
Catalogue
Search and filter all 695 devicesShowing 1-50 of 695
Company details
- EUDAMED SRN
- CN-MF-000009957
- EUDAMED status
- Active
- EUDAMED registered name
- Edan Instruments,Inc.
- EUDAMED abbreviated name
- Edan
- Registered address
- 15, Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District, 518122, Shenzhen, China
- reg02@edan.com
- PRRC contact
- Yongying Liu
FDA establishments
- Edan Instruments, Inc. US
Frequently asked questions
How many devices does Edan Instruments,Inc. have in the registry?
The registry currently lists 695 devices for Edan Instruments,Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edan Instruments,Inc.'s devices?
Among its 50 most recently registered devices, Edan Instruments,Inc. has devices listed in EUDAMED (48 devices), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Edan Instruments,Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Edan Instruments,Inc.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Edan Instruments,Inc. in the registry?
The most recently registered devices listed for Edan Instruments,Inc. include SpO2 sensor, NIBP Cuff, Temperature Probe and Biofeedback and Stimulation System.
Which FDA establishments are linked to Edan Instruments,Inc.?
1 FDA establishment is linked to Edan Instruments,Inc. in the registry; they are listed on the company page.