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Hemoglobin Test Strips and Hemoglobin Meter
EUDAMEDClass IVD General (EU MDR)
Ref AS-XH-02, HBM-W11Model AS-XH-02,HBM-W11
Identity
- Trade Name
- Hemoglobin Test Strips and Hemoglobin Meter EUDAMED
- Device Name
- Hemoglobin Test Strips and Hemoglobin Meter EUDAMED
- Model / Reference
- AS-XH-02,HBM-W11 EUDAMEDAS-XH-02, HBM-W11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804813673 EUDAMED
- Basic UDI-DI
- B-06952804813673 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class IVD General 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
Hemoglobin Test Strips and Hemoglobin Meter by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06952804813673 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 626cc9c8-a5e6-4c96-bc9c-c188fa5e2045 61 fields · synced Jun 19, 2026
- EUDAMED 626cc9c8-a5e6-4c96-bc9c-c188fa5e2045-1 61 fields · synced Jun 10, 2026