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Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R
FDA UDIFDA 510(k)EUDAMEDClass II (US FDA UDI)
510(k) K200904
Identity
- Trade Name
- Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
- Device Name
- Glycated Hemoglobin (HbA1C) Analyzer IVD FDA UDI
- Model / Reference
- HLC-723G8R FDA UDI
- Description
- Glycated Hemoglobin (HbA1C) Analyzer IVD FDA UDI
Identifiers
- Catalog Number
- 021560R FDA UDI
- Primary DI / UDI-DI
- 00853931008009 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glycated haemoglobin (HbA1C) analyser IVD
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R by Tosoh Bioscience, Inc. — Class II — FDA_510K, IVDR — listed in FDA GUDID, FDA 510(k), EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Unknown
IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131580 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200904 | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (3)
- FDA UDI 76296d1c-f70d-4b59-a4bd-961586c99054 59 fields · synced Jun 19, 2026
- FDA 510(k) K131580 1 fields · synced Jun 5, 2026
- EUDAMED 1 fields · synced Jun 3, 2026