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MultiSure GK
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref S84005Ref S5640465, S5640466Ref S5800269
Identity
- Trade Name
- MultiSure GK EUDAMED
- Device Name
- MultiSure GK Blood Glucose and Ketone Monitoring System EUDAMEDMultiSure GK blood ketone test strips EUDAMEDMultiSure GK ketone control solution EUDAMED
- Model / Reference
- S84005 EUDAMEDS5640465, S5640466 EUDAMEDS5800269 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487612A05V EUDAMEDD-47136487612AKT27 EUDAMEDD-47136487612AKS25 EUDAMED
- Basic UDI-DI
- B-47136487612A05V EUDAMEDB-47136487612AKT27 EUDAMEDB-47136487612AKS25 EUDAMED
- EMDN Code
- W01010118,W01010213 EUDAMEDW0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMEDW010106010801 BLOOD TEST STRIPS CONTROLS 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
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
MultiSure GK 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-47136487612A05V | 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 (4)
- EUDAMED 5f1dd16b-1dea-4fd8-9ed7-bcedd91027af 61 fields · synced Jul 17, 2026
- EUDAMED 33ef8b8a-7a37-4fd5-bbfe-fcbe4dfdd892 61 fields · synced May 18, 2026
- EUDAMED dfbcd999-10bf-4d45-8bc3-e9fd54239acb 61 fields · synced May 18, 2026
- EUDAMED 33ef8b8a-7a37-4fd5-bbfe-fcbe4dfdd892-1 61 fields · synced Jul 10, 2026