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Hemoglobin Analyzer(HPLC)
EUDAMEDClass A (EU MDR)
Ref NAModel H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,
Identity
- Trade Name
- Hemoglobin Analyzer(HPLC) EUDAMED
- Device Name
- Hemoglobin Analyzer(HPLC) EUDAMED
- Model / Reference
- H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10, EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062822 EUDAMED
- Basic UDI-DI
- 6970341680120203GU EUDAMED
- Direct Marketing DI
- 06975984062822 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Hemoglobin Analyzer(HPLC) by Shenzhen Lifotronic Technology 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 | 6970341680120203GU | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 3fdafb04-45c9-4ddf-8b16-38aa3434d718 61 fields · synced Aug 2, 2026
- EUDAMED 3fdafb04-45c9-4ddf-8b16-38aa3434d718-1 61 fields · synced Jun 10, 2026