Biometer Intl. A/S
DK Last updated 22 Oct 2026
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- Devices
- 9
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Am 706 Electromyograph, Stim., Neuro., External Ref K881196
Elpha 2000 Ref K914231
Tof-Guard Transmission Monitor Ref K925159
Myotest Dbs Nerve Stimulator Ref K890746
Mini Accelograph Neuromuscular Trans. Monitor Ref K892396
Accelograph Neuromuscular Transmission Monitor Ref K893485
Myotest - Nerve Stimulator Ref K860186
Accelograph Ref K870619
What Biometer Intl. A/S makes
Biometer Intl. A/S manufactures external neuromuscular and neurostimulation devices, including electromyography (EMG) stimulators, nerve stimulators, and neuromuscular transmission monitors. Their portfolio includes tools for assessing nerve and muscle function, such as the Myotest nerve stimulator and the Accelograph neuromuscular transmission monitor. Additional products include specialized monitoring systems like the TOF-Guard transmission monitor and the Myograph 2000 for recording and assessing neurophysiological responses.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database. Biometer Intl. A/S operates from the United States.
Frequently asked questions
What types of medical devices does Biometer Intl. A/S manufacture?
Biometer Intl. A/S specializes in external neuromuscular and neurostimulation devices. Their portfolio includes electromyography (EMG) stimulators, nerve stimulators, and neuromuscular transmission monitors. Examples include the Myotest nerve stimulator, Accelograph neuromuscular transmission monitor, and the TOF-Guard transmission monitor, which are designed for assessing nerve and muscle function, as well as recording neurophysiological responses.
Where is Biometer Intl. A/S based?
Biometer Intl. A/S operates from the United States. The company’s headquarters or primary operational location is in the US, though specific regional offices or subsidiaries may exist elsewhere.
Which regulatory registries list Biometer Intl. A/S’s devices?
Biometer Intl. A/S’s devices are listed in the FDA’s 510(k) database. This registry includes devices that have been authorised through the 510(k) premarket notification process, which is used for Class II medical devices like those produced by the company.
How are Biometer Intl. A/S’s devices classified under FDA regulations?
Biometer Intl. A/S’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as pre-market notification (510(k)) submissions to demonstrate substantial equivalence to a predicate device.
Information
- Country
- DK