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GlucoSure Advance II
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref S5640626 S5640680 S5640679 S5641126Ref S70335 S70350 S70512 S70513 S70514
Identity
- Trade Name
- GlucoSure Advance II EUDAMED
- Device Name
- GlucoSure Advance II Blood Glucose Test Strips EUDAMEDGlucoSure Advance II Blood Glucose Monitoring System EUDAMED
- Model / Reference
- S5640626 S5640680 S5640679 S5641126 EUDAMEDS70335 S70350 S70512 S70513 S70514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487603C1TXX EUDAMEDD-47136487603C163 EUDAMED
- Basic UDI-DI
- B-47136487603C1TXX EUDAMEDB-47136487603C163 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMEDW0101060101,W010106010801,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
GlucoSure Advance II by Apex Biotechnology Corp. — Class IVD Annex II List B — 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-47136487603C1TXX | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d4f514b5-c13e-4b7f-96f2-d7c6baf4f04d 61 fields · synced Jul 26, 2026
- EUDAMED bab1282d-8ed2-4a5f-ad18-55b6331f7381 61 fields · synced May 18, 2026