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Blood Glucose and β-Ketone Test Meter
EUDAMEDClass A (EU MDR)
Ref 69528048C9040002XModel GKE-101
Identity
- Trade Name
- Blood Glucose and β-Ketone Test Meter EUDAMED
- Device Name
- Blood Glucose and β-Ketone Test Meter EUDAMED
- Model / Reference
- GKE-101 EUDAMED69528048C9040002X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804834982 EUDAMED
- Basic UDI-DI
- 69528048C9040002X 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 β-Ketone 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 | 69528048C9040002X | 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 04cc24d1-3dfd-424d-96b0-6efac4aae8e4 61 fields · synced Jun 19, 2026