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Hemoglobin Analyzer(HPLC)
EUDAMEDClass A (EU MDR)
Ref 0120225Model H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10, Ref 0120215Ref 0120226Ref 012020505Ref 012020405
Identity
- Trade Name
- Hemoglobin Analyzer(HPLC) EUDAMED
- Device Name
- Hemoglobin Analyzer(HPLC) EUDAMED
- Model / Reference
- H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10, EUDAMED0120225 EUDAMED0120215 EUDAMED0120226 EUDAMED012020505 EUDAMED012020405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685027 EUDAMED06970341680237 EUDAMED06975984061948 EUDAMED06975984066424 EUDAMED06975984066431 EUDAMED
- Basic UDI-DI
- 6970341680120203GU EUDAMED
- Direct Marketing DI
- 06970341680237 EUDAMED
- EMDN Code
- W0201050201 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS EUDAMEDW0201060101 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 (5)
- EUDAMED 43a88ddb-358d-4c6e-877c-dba444fce8ce 61 fields · synced Jul 31, 2026
- EUDAMED 98ef6cb8-ac06-41ab-8183-18cab36cd41a 61 fields · synced May 17, 2026
- EUDAMED b3cfba9d-9273-4a5b-bfe2-6ffa89182891 61 fields · synced May 17, 2026
- EUDAMED 1caba346-f0af-477b-99a7-61a6831e27af 61 fields · synced May 18, 2026
- EUDAMED d66208c8-42c9-438f-9286-d2c4e99ffbd3 61 fields · synced May 18, 2026