New Medical Technologies GmbH
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 22 ongoing
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What New Medical Technologies GmbH makes
New Medical Technologies GmbH manufactures cryopreservation systems, including devices for tissue and cell storage under controlled freezing conditions. The portfolio includes models for cryoprotectant delivery systems, storage containers, and automated freezing units designed for clinical and research applications.
These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 2
- 2025 0
- 2026 0
2024
- 19 Dec 2024 Z-1103-2025 Class II Ongoing During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
Full distribution text
- 19 Dec 2024 Z-1104-2025 Class II Ongoing During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
Full distribution text
- 19 Dec 2024 Z-1103-2025 Class II Ongoing During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
FDA establishments
- New Medical Technologies GmbH Bern · CH FEI 3008252257
Frequently asked questions
How many devices does New Medical Technologies GmbH have in the registry?
The registry currently lists 1 device for New Medical Technologies GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Medical Technologies GmbH's devices?
Among its 1 most recently registered device, New Medical Technologies GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do New Medical Technologies GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for New Medical Technologies GmbH's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for New Medical Technologies GmbH?
FDA recall records list 2 recalls initiated by New Medical Technologies GmbH, the most recent initiated on 19 Dec 2024. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from New Medical Technologies GmbH in the registry?
The most recently registered devices listed for New Medical Technologies GmbH include CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23.
Which FDA establishments are linked to New Medical Technologies GmbH?
1 FDA establishment is linked to New Medical Technologies GmbH in the registry; they are listed on the company page.