Andwin Scientific
United Statesfrom the FDA registration address FDA FEI 2027344
Andwin Scientific is a medical device manufacturer, with 36 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.
- Devices
- 36
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 33
- FDA 510(k) 3
- Device classes
- FDA Class II 30
- FDA Class I 6
- Identifiers
- FDA FEI 2027344
- DUNS 028449445
At a glance
Market reach
- United States
- FDA FEI
What Andwin Scientific makes
Andwin Scientific manufactures cervical cytology brushes, Papanicolaou smear kits, vial/bottle adaptors (non-hermetic), and single-use cervical cytology scrapers. Example devices include Papette and SealSafe products.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
Search and filter all 36 devicesCompany details
- FDA FEI number
- 2027344
- DUNS number
- 028449445
- Address
- 167 W. Cochran St., Simi Valley, CA, 93065
- Website
- www.sealsafe.com
- facebook.com/sealsafe
- info@andwin.com
From the company website
SEALSAFE are Self Sealing Dosing Adatpers used for safe dosing of medication. Made in the USA at the Andwin Corporation facility, in Simi Valley, California.
Frequently asked questions
How many devices does Andwin Scientific have in the registry?
The registry currently lists 36 devices for Andwin Scientific. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andwin Scientific's devices?
Among its 36 most recently registered devices, Andwin Scientific has devices listed in FDA 510(k) (3 devices) and FDA GUDID (33 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Andwin Scientific's devices fall under?
Among its 36 most recently registered devices, the classes recorded for Andwin Scientific's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andwin Scientific in the registry?
The most recently registered devices listed for Andwin Scientific include Andwin Scientific 231048, SealSafe 760020S, Andwin Scientific 230160 and Andwin Scientific 892035.