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Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0021674
Identity
- Trade Name
- Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA EUDAMEDFDA UDI
- Generic Name
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
- Device Name
- Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 EUDAMED
- Model / Reference
- 0021674 EUDAMEDHLC-723G8 LA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189282926 EUDAMEDFDA UDI
- Basic UDI-DI
- 45601892100040027H EUDAMED
- FDA Product Code
- LCP FDA UDI
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA by Tosoh Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 45601892100040027H | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 789c9723-cc13-44ef-a46b-1caf6cd27177 61 fields · synced Jul 10, 2026
- FDA UDI e8bbf0e4-a6fb-4912-9fea-4de5f6e3347e 34 fields · synced May 30, 2026