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lisubel®check LB-EMV4 Glucose Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref LB-EMV4Model Glucose Test Strip
Identity
- Trade Name
- lisubel®check LB-EMV4 Glucose Test Strip EUDAMEDlisubel®check LB-EMV4 Glucose Test Strip [ES] EUDAMED
- Device Name
- lisubel®check LB-EMV4 Glucose Test Strip EUDAMED
- Model / Reference
- Glucose Test Strip EUDAMEDLB-EMV4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08470001867025 EUDAMED
- Basic UDI-DI
- B-08470001867025 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
lisubel®check LB-EMV4 Glucose Test Strip by Eps Bio Technology Corp. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-08470001867025 | 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 (2)
- EUDAMED bdf35fc7-4af3-451d-beab-0bda4bb7c9d0 61 fields · synced Jul 8, 2026
- EUDAMED 46ea9711-c0ec-41b1-8ab7-554b0c86b0a7 61 fields · synced Jul 8, 2026