Identity
- Trade Name
- AlcoMate FDA UDI
- Generic Name
- Alcohol breath analyser FDA UDI
- Device Name
- Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly. FDA UDI
- Model / Reference
- SM200 FDA UDI
- Description
- Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly. FDA UDI
Identifiers
- Catalog Number
- AKG-SM200 FDA UDI
- Primary DI / UDI-DI
- 00853464001348 FDA UDI
- FDA Product Code
- OIC FDA UDIDJZ FDA UDI
- GMDN Term
- Alcohol breath analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3040 FDA UDI862.3050 FDA UDI
- Commercial Distribution
- 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alcohol breath analyser
AlcoMate by Ak Globaltech Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ak Globaltech Corp
Sources (1)
- FDA UDI cb43783b-521e-4d0e-89dd-2c1bc1cd0dbd 36 fields · synced May 30, 2026