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HLC-100 Automatic Glycosylated Hemoglobin Analyzer
EUDAMEDClass A (EU MDR)
Ref BT0000601Model HLC-100
Identity
- Device Name
- HLC-100 Automatic Glycosylated Hemoglobin Analyzer EUDAMED
- Model / Reference
- HLC-100 EUDAMEDBT0000601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260212347 EUDAMED
- Basic UDI-DI
- 69332602IT0100007A5 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMEDEUDAMED
HLC-100 Automatic Glycosylated Hemoglobin Analyzer by Xiamen Biotime Biotechnology Co., Ltd. — 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 | 69332602IT0100007A5 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED ccc38e4e-77e3-4c81-a4a2-39493a0d26ac 61 fields · synced Oct 6, 2026
- EUDAMED 3df86f25-4a6c-431c-8f00-a498e7dfbc44 61 fields · synced Jul 15, 2026