Identity
- Trade Name
- AlcoMate FDA UDI
- Generic Name
- Alcohol breath analyser FDA UDI
- Device Name
- AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS600 is a highly-upgraded professional breathalyzer for measuring alcohol in human breath. Test results can be stored on TS600 or printed out the data through wired or wireless (optional) connecting with mobile printer. FDA UDI
- Model / Reference
- TS600 FDA UDI
- Description
- AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS600 is a highly-upgraded professional breathalyzer for measuring alcohol in human breath. Test results can be stored on TS600 or printed out the data through wired or wireless (optional) connecting with mobile printer. FDA UDI
Identifiers
- Catalog Number
- AKG-TS600 FDA UDI
- Primary DI / UDI-DI
- 00853464001379 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
Yes
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 9956f4bd-c03e-4125-a5e6-4617939e35be 36 fields · synced May 30, 2026