Galenica Enterprises, Inc.
Country not established
- Devices
- 5
What Galenica Enterprises, Inc. makes
Galenica Enterprises, Inc. manufactures single-use medical devices for obstetrics and gynecological procedures, including disposable amniotomes for amniotomy, vaginal specula for pelvic examinations, and disposable anoscope systems for rectal examinations. The company also produces disposable external clamps for medical applications and lighting source systems for procedural illumination.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their authorised status under U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Lighting Source System Ref K923656
Regimes: 510(k) Registry: 510(k)Disposable Amniotome Ref K883283
Regimes: 510(k) Registry: 510(k)Vaginal Speculum - Disposable Ref K841909
Regimes: 510(k) Registry: 510(k)Galenica's Disposable Anoscopes Ref K861017
Regimes: 510(k) Registry: 510(k)Disposable External Clamps Ref K896383
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Galenica Enterprises, Inc. have in the registry?
The registry currently lists 5 devices for Galenica Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Galenica Enterprises, Inc.'s devices?
Among its 5 most recently registered devices, Galenica Enterprises, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Galenica Enterprises, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Galenica Enterprises, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Galenica Enterprises, Inc. in the registry?
The most recently registered devices listed for Galenica Enterprises, Inc. include LIGHTING SOURCE SYSTEM, DISPOSABLE AMNIOTOME, VAGINAL SPECULUM - DISPOSABLE and GALENICA'S DISPOSABLE ANOSCOPES.