Identity
- Trade Name
- Alpine BioMed FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- "Keypoint Focus Workstation, FRA Including: - USFF PC with Keypoint software, MS Office, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit" FDA UDI
- Model / Reference
- 9033A072102 FDA UDI
- Description
- "Keypoint Focus Workstation, FRA Including: - USFF PC with Keypoint software, MS Office, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704736017244 FDA UDI
- 510(k) Number
- K944547 FDA UDI
- FDA Product Code
- GWF FDA UDI
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alpine BioMed by Alpine Biomed Aps — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alpine Biomed Aps
Sources (1)
- FDA UDI 3a81833e-9c10-4fbb-a82b-a061bb15d4f0 35 fields · synced Jun 1, 2026