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Sign in to claim this brandAlpine Biomed Aps
US
Last updated May 23, 2026
What Alpine Biomed Aps makes
Alpine Biomed manufactures electromyography (EMG) systems, including portable workstation and notebook configurations designed for clinical and diagnostic use. These devices are intended for assessing muscle and nerve function through electrical activity measurements, supporting evaluations in neuromuscular disorders and rehabilitation settings.
The company’s products fall under FDA Class II regulatory classification and are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States, adhering to U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Alpine Biomed Aps manufacture?
Alpine Biomed Aps specializes in electromyography (EMG) systems, which include portable workstations and notebook configurations. These devices measure electrical activity in muscles and nerves to help diagnose and monitor neuromuscular disorders, making them useful in clinical and rehabilitation settings.
Where is Alpine Biomed Aps based, and how does that affect its devices?
Alpine Biomed Aps is based in the United States, meaning its devices are designed and manufactured in compliance with U.S. medical device regulations. This includes adherence to FDA requirements, which govern the classification, registration, and listing of its products.
How are Alpine Biomed Aps’s devices classified by regulatory authorities?
Alpine Biomed Aps’s devices are classified as Class II by the FDA, indicating a moderate level of risk that requires special controls to ensure safety and effectiveness. This classification influences how the devices are reviewed, registered, and monitored by regulatory bodies.
Which regulatory registries list Alpine Biomed Aps’s devices?
Alpine Biomed Aps’s devices are listed in the FDA’s 510(k) Premarket Notification Database and the FDA’s Unique Device Identifier (UDI) System. These registries track device approvals, classifications, and compliance to ensure transparency in the medical device market.
Why are Alpine Biomed Aps’s EMG systems considered Class II devices?
The FDA categorizes EMG systems as Class II because they pose a moderate risk to patients when used improperly or without proper controls. While they don’t require the same stringent pre-market approval as Class III devices, they still need validated performance standards, labeling requirements, and post-market surveillance to ensure safe and effective use in diagnosing neuromuscular conditions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 311231554
Catalogue (192)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alpine BioMed | 9031E0154 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9013R0213 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033C0731 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A072104 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 8031C0511 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A006402 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031C0782 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A0821GN | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A0711AA | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9031E0268 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A082101 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A072143 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9031C0512 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9013L0862 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031E0153 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031E0155 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A006502 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A006505 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A0701HA | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A070104 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031D0303 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9031C0521 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A051406 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031C0503 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A0721GN | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A071101 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9013C0532 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9015A0012 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A081103 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031C5623 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031C0501 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9031C0601 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A051303 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9013C0142 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031C0881 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9033A0821BV | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031C0732 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9013L4402 | FDA UDI | Class II | Unknown |
| Alpine Biomed | 9031E0116 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A006405 | FDA UDI | Class II | Unknown |
| Alpine BioMed | 9031A051402 | FDA UDI | Class II | Unknown |
| Leadpoint Focus Workststion, Leadpoint Focus Notebook System | K140680 | FDA 510(k) | Class II | Active |
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