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Blood Glucose and Uric Acid and Total Cholesterol Test Meter
EUDAMEDClass A (EU MDR)
Ref GUC-101
Identity
- Trade Name
- Blood Glucose and Uric Acid and Total Cholesterol Test Meter EUDAMED
- Device Name
- Blood Glucose and Uric Acid and Total Cholesterol Test Meter EUDAMED
- Model / Reference
- GUC-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804813178 EUDAMED
- Basic UDI-DI
- 69528048C913F006C 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
Blood Glucose and Uric Acid and Total Cholesterol Test Meter by Assure Tech. (hangzhou) Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 69528048C913F006C | Class A | 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 (1)
- EUDAMED 89ce5041-f56f-440f-8e5a-c536de0c2051 61 fields · synced Jun 19, 2026