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Avital Blood Glucose Monitoring System
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 6276
Identity
- Trade Name
- Avital Blood Glucose Monitoring System EUDAMEDSmartest Persona II Multi Blood Glucose Monitoring System FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- Avital Blood Glucose Monitoring System EUDAMED
- Model / Reference
- 6276 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04712803566770 EUDAMED04712803564141 FDA UDI
- Basic UDI-DI
- B-04712803566770 EUDAMED
- 510(k) Number
- K133509 FDA UDI
- FDA Product Code
- NBW FDA UDICGA FDA UDIJJX FDA UDI
- EMDN Code
- W0101060101,W0201060102 EUDAMED
- GMDN Term
- Glucose monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1660 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Avital Blood Glucose Monitoring System by Ok Biotech Co., Ltd. — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04712803566770 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
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Manufacturer
- Manufacturer
- OK biotech co., Ltd
- EUDAMED SRN
- TW-MF-000028031
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cd34b999-f22a-4b7e-b74f-7b11368122fb 61 fields · synced Oct 6, 2026
- FDA UDI c88d5e95-0434-4a56-b42e-04cb39804284 33 fields · synced May 30, 2026