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Hemoglobin A1c Eluent B
EUDAMEDClass A (EU MDR)
Ref 105-048454-00Model 105-048455-00/105-048453-00/105-048454-00/105-048464-00
Identity
- Trade Name
- Hemoglobin A1c Eluent B EUDAMED
- Device Name
- Hemoglobin A1c Hemolysis Solution EUDAMED
- Model / Reference
- 105-048455-00/105-048453-00/105-048454-00/105-048464-00 EUDAMED105-048454-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053088961 EUDAMED
- Basic UDI-DI
- 69449040AB700001945 EUDAMED
- EMDN Code
- W0103010299 OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hemoglobin A1c Eluent B by Shenzhen Mindray Bio-Medical Electronics 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 | 69449040AB700001945 | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 43beb61d-c03a-4b41-bf6a-cbc160568abd 61 fields · synced Jun 19, 2026