Obtech Medical GmbH
Country not established
- Devices
- 1
What Obtech Medical GmbH makes
Obtech Medical GmbH manufactures adjustable gastric bands, including systems with integrated injection ports and applicators designed for bariatric surgery. These devices are intended for laparoscopic placement and subsequent adjustment via subcutaneous injections to manage weight loss in patients with obesity.
The company’s portfolio is regulated under Class III devices in the U.S., requiring Premarket Approval (PMA) through the FDA. The devices are listed in the FDA’s PMA registry, adhering to stringent premarket authorisation requirements for high-risk medical products. The manufacturer is based in the United States.
Catalogue
- Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Obtech Medical GmbH have in the registry?
The registry currently lists 1 device for Obtech Medical GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Obtech Medical GmbH's devices?
Among its 1 most recently registered device, Obtech Medical GmbH has devices listed in FDA PMA (1 device).
What risk classes do Obtech Medical GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Obtech Medical GmbH's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Obtech Medical GmbH in the registry?
The most recently registered devices listed for Obtech Medical GmbH include REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER.