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Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref EG-101，EG-102，EGS-101Ref GOH-101Pro
Identity
- Trade Name
- Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip) EUDAMEDBlood Glucose Test Meter EUDAMED
- Device Name
- Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip) EUDAMEDBlood Glucose Test Meter EUDAMED
- Model / Reference
- EG-101，EG-102，EGS-101 EUDAMEDGOH-101Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804817701 EUDAMED06952804835033 EUDAMED
- Basic UDI-DI
- B-06952804817701 EUDAMED69528048GOH-101ProH4 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass 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
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip) by Assure Tech. (hangzhou) Co., Ltd. — Class IVD Annex II List B — IVDR, IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06952804817701 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-06952804817701 | Class IVD Annex II List B | 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 0427de21-b6e5-4e93-9674-4c6bd96c1700 61 fields · synced Oct 6, 2026
- EUDAMED 5b5f0b16-829d-4a25-bb39-6c9746cfd2d3 61 fields · synced Jul 31, 2026