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EasyMax Blood Glucose Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 681.74Model EASYMAXModel Glucose Test StripRef 681.99Ref 681.87Ref 681.86
Identity
- Trade Name
- EasyMax Blood Glucose Test Strip EUDAMEDEASYMAX® Blood Glucose Test Strip[EN] EUDAMEDEASYMAX® Blood Glucose Test Strip EUDAMED
- Device Name
- EASYMAX® Blood Glucose Test Strip EUDAMED
- Model / Reference
- EASYMAX EUDAMED681.74 EUDAMEDGlucose Test Strip EUDAMED681.99 EUDAMED681.87 EUDAMED681.86 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713945681741 EUDAMED04713945681994 EUDAMED04713945681871 EUDAMED04713945681864 EUDAMED
- Basic UDI-DI
- B-04713945681741 EUDAMEDB-04713945681994 EUDAMEDB-04713945681871 EUDAMEDB-04713945681864 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
EasyMax Blood Glucose Test Strip by Eps Bio Technology Corp. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04713945681741 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- EPS Bio Technology Corp.
- EUDAMED SRN
- TW-MF-000028384
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 1eb04337-65ec-4129-b993-0ff4da501188 61 fields · synced Sep 17, 2026
- EUDAMED 4555a4bd-24ab-4210-9802-3568e995252a 61 fields · synced Jul 9, 2026
- EUDAMED 07d58bf6-a484-4fb0-bb5d-567403e3d422 61 fields · synced Jul 11, 2026
- EUDAMED 262d2865-0328-4502-bace-a3006c398c3a 61 fields · synced Jul 21, 2026
- EUDAMED a0efcdbf-a897-48be-9169-058861d39b6c 61 fields · synced Sep 17, 2026