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Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I
EUDAMEDClass A (EU MDR)
Ref AGKUCR-100ST10Model InstrumentRef AGKUCR-200ST5Ref AGKUCR-200Ref AGKUCR-100ST5
Identity
- Trade Name
- Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I EUDAMEDBlood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II EUDAMED
- Device Name
- Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system Ⅰ EUDAMEDBlood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II EUDAMED
- Model / Reference
- Instrument EUDAMEDAGKUCR-100ST10 EUDAMEDAGKUCR-200ST5 EUDAMEDAGKUCR-200 EUDAMEDAGKUCR-100ST5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983164818 EUDAMED06936983164832 EUDAMED06936983164825 EUDAMED06936983164801 EUDAMED
- Basic UDI-DI
- 6970277510019QZB EUDAMED6970277510019RZD EUDAMED
- Direct Marketing DI
- 06936983164818 EUDAMED06936983164832 EUDAMED06936983164825 EUDAMED06936983164801 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I by Hangzhou Alltest Biotech.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 | 6970277510019QZB | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 185f8d6a-ee21-4940-bc33-9afafaf5776c 61 fields · synced Oct 6, 2026
- EUDAMED 4e593e53-1831-4adc-b8b9-b8ec342f87e8 61 fields · synced May 16, 2026
- EUDAMED e708bfc0-e3e2-45f0-a556-35e5cf6ce486 61 fields · synced May 16, 2026
- EUDAMED f91f1e3e-799d-445d-9542-63ff078b8a77 61 fields · synced May 17, 2026