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MultiSure GCTU
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref S81001, S81002Ref S5800342Ref S5640826 S5640829 S5640825 S5640827 S5640831 S5640828 S5640830Ref S5800344 S5800345Ref S5800343 S5800346
Identity
- Trade Name
- MultiSure GCTU EUDAMEDMultiSure EUDAMED
- Device Name
- MultiSure GCTU Monitoring System EUDAMEDMultiSure Triglyceride Control Solution EUDAMEDMultiSure Cholesterol Test Strip EUDAMEDMultiSure Cholesterol Control Solution EUDAMEDMultiSure Uric Acid Control Solution EUDAMED
- Model / Reference
- S81001, S81002 EUDAMEDS5800342 EUDAMEDS5640826 S5640829 S5640825 S5640827 S5640831 S5640828 S5640830 EUDAMEDS5800344 S5800345 EUDAMEDS5800343 S5800346 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487613A062 EUDAMEDD-47136487613ATS37 EUDAMEDD-47136487613ACTZK EUDAMEDD-47136487613ACSZH EUDAMEDD-47136487613AUS3A EUDAMED
- Basic UDI-DI
- B-47136487613A062 EUDAMEDB-47136487613ATS37 EUDAMEDB-47136487613ACTZK EUDAMEDB-47136487613ACSZH EUDAMEDB-47136487613AUS3A EUDAMED
- EMDN Code
- W0101060101,W0101060102,W0101060105,W010106010801,W0101060199,W020106019099 EUDAMEDW010106010801 BLOOD TEST STRIPS CONTROLS EUDAMEDW0101060102 CHOLESTEROL TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass IVD devices for self-testing EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
MultiSure GCTU 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-47136487613A062 | 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 (6)
- EUDAMED 21439d64-2777-40f0-aa9f-419125b384dc 61 fields · synced Jul 30, 2026
- EUDAMED 21439d64-2777-40f0-aa9f-419125b384dc-1 61 fields · synced Jun 10, 2026
- EUDAMED b6a3092d-cac0-4969-a6a8-bbf34e8d953c 61 fields · synced Jul 9, 2026
- EUDAMED f0c5d370-a677-4244-8e7a-846c18678f85 61 fields · synced Jul 10, 2026
- EUDAMED 81f62b75-9db9-4e66-8c9b-a281d603bc8b 61 fields · synced Jul 19, 2026
- EUDAMED c528b725-9aec-47a5-ac30-c7d5fc615635 61 fields · synced Jul 30, 2026