Harps Europe Manufacturing GmbH
AustriaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Harps Europe Manufacturing GmbH makes
Harps Europe Manufacturing GmbH produces sterile, powder-free synthetic rubber surgeon’s gloves in green color, designed for use with chemotherapy drugs and gastric acid. These gloves are intended for single-use surgical procedures requiring chemical resistance and barrier protection.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Harps Europe Manufacturing WIMPASSING NIEDEROSTERREICH · AT FEI 3007478974
Frequently asked questions
How many devices does Harps Europe Manufacturing GmbH have in the registry?
The registry currently lists 1 device for Harps Europe Manufacturing GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harps Europe Manufacturing GmbH's devices?
Among its 1 most recently registered device, Harps Europe Manufacturing GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Harps Europe Manufacturing GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Harps Europe Manufacturing GmbH's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Harps Europe Manufacturing GmbH in the registry?
The most recently registered devices listed for Harps Europe Manufacturing GmbH include Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid.
Which FDA establishments are linked to Harps Europe Manufacturing GmbH?
1 FDA establishment is linked to Harps Europe Manufacturing GmbH in the registry; they are listed on the company page.