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EasyMax MU Self Monitoring Blood Glucose System
EUDAMEDFDA 510(k)Class IVD devices for self-testing (EU MDR)
Ref 680.88Model EasyMax MU 510(k) K121207Ref 680.82Ref 681.00
Identity
- Trade Name
- EasyMax MU Self Monitoring Blood Glucose System EUDAMEDEasyMax MU Self Monitoring Blood Glucose System [EN] EUDAMED
- Device Name
- EasyMax MU Self Monitoring Blood Glucose System EUDAMED
- Model / Reference
- EasyMax MU EUDAMED680.88 EUDAMED680.82 EUDAMED681.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713945680881 EUDAMED04713945680829 EUDAMED04713945681000 EUDAMED
- Basic UDI-DI
- B-04713945680881 EUDAMEDB-04713945680829 EUDAMEDB-04713945681000 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
EasyMax MU Self Monitoring Blood Glucose System by Eps Bio Technology Corp. — Class IVD devices for self-testing — FDA_510K, IVDD — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121207 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-04713945680881 | 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 (6)
- EUDAMED 09ab78f6-a378-4077-a583-7f8600187a02 85 fields · synced Jul 9, 2026
- EUDAMED 4dc220d1-081a-4f22-ad4f-76ed9508a3b0 61 fields · synced May 18, 2026
- EUDAMED ca603cc6-8bb9-4fb3-9465-1ca06bf5077b 61 fields · synced May 18, 2026
- EUDAMED 2ee50f71-eaee-4da0-a5b6-b84bfa216941 61 fields · synced Jun 19, 2026
- EUDAMED 8da607e1-983b-4842-a451-dc0f857a4fe6 61 fields · synced Jul 9, 2026
- FDA 510(k) K121207 1 fields · synced May 18, 2026