Identity
- Trade Name
- 90 Sample Loader G11-90SL EUDAMED
- Device Name
- Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 EUDAMED
- Model / Reference
- 0023852 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562185396881 EUDAMED
- Basic UDI-DI
- 45601892100040027H EUDAMED
- EMDN Code
- W020106019080 VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
90 Sample Loader G11-90SL by Tosoh Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 45601892100040027H | Class A | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (1)
- EUDAMED 07e00ddc-9ba2-441f-8e86-a30e6f923515 61 fields · synced Jul 13, 2026