Identity
- Trade Name
- G6PD and Hemoglobin Biosensor Test Meter EUDAMED
- Device Name
- G6PD and Hemoglobin Biosensor Test Meter EUDAMED
- Model / Reference
- GPHB-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804835071 EUDAMED
- Basic UDI-DI
- 69528048GPHB-101UT EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER 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
G6PD and Hemoglobin Biosensor Test Meter by Assure Tech. (hangzhou) 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 | 69528048GPHB-101UT | Class A | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 5b93688e-d5a1-45c3-8e50-b2601e6e7494 61 fields · synced Jun 19, 2026