Berwick Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Berwick Medical Products, Inc. makes
Berwick Medical Products, Inc. manufactures single-use laboratory pipettes, including plastic disposable pipets designed for liquid handling, and prefilled ion-exchange chromatography columns for analytical applications. Their product line also includes systems like the ISO-SEP, which appear to be designed for sample preparation or separation processes in laboratory settings.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions listed under the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight for compliance with medical device regulations.
Catalogue
Iso-Sep System Ref K842018
Regimes: 510(k) Registry: 510(k)Dropstirs - Plastic Disposable Pipet Ref K850800
Regimes: 510(k) Registry: 510(k)Prefilled Iec Columns Ref K831289
Regimes: 510(k) Registry: 510(k)Iso-Sep System Ref K831434
Regimes: 510(k) Registry: 510(k)I.E.C Column Ref K830918
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Berwick Medical Products, Inc. have in the registry?
The registry currently lists 5 devices for Berwick Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Berwick Medical Products, Inc.'s devices?
Among its 5 most recently registered devices, Berwick Medical Products, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Berwick Medical Products, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Berwick Medical Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Berwick Medical Products, Inc. in the registry?
The most recently registered devices listed for Berwick Medical Products, Inc. include ISO-SEP SYSTEM, DROPSTIRS - PLASTIC DISPOSABLE PIPET, PREFILLED IEC COLUMNS and I.E.C COLUMN.