← Back to catalogue
GlucoSure Link
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref S70453, S70454, S70455Ref S70453 S70454 S70455
Identity
- Trade Name
- GlucoSure Link EUDAMED
- Device Name
- GlucoSure Link Blood Glucose Monitoring System EUDAMEDGlucoSure Link Blood Glucose test strips EUDAMED
- Model / Reference
- S70453, S70454, S70455 EUDAMEDS70453 S70454 S70455 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487601A15K EUDAMEDD-47136487601A1TX7 EUDAMED
- Basic UDI-DI
- B-47136487601A15K EUDAMEDB-47136487601A1TX7 EUDAMED
- EMDN Code
- W0101060101,W010106010801,W0201060102 EUDAMEDW0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
EUDAMEDEUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
GlucoSure Link 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-47136487601A15K | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 4cd063a5-0b9e-4f9b-b90c-ba38c0cdf894 61 fields · synced Jul 12, 2026
- EUDAMED 7ca51fd1-225e-45be-b01e-3fe8868eb000 61 fields · synced Jul 12, 2026