Identity
- Trade Name
- KETOSURE POC EUDAMED
- Device Name
- KetoSure POC Blood Ketone Monitoring System EUDAMEDKETOSURE POC Blood Ketone Test Strips EUDAMED
- Model / Reference
- S11015 EUDAMEDS5640894 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487609B06U EUDAMEDD-47136487609BKT3J EUDAMED
- Basic UDI-DI
- B-47136487609B06U EUDAMEDB-47136487609BKT3J EUDAMED
- EMDN Code
- W01010118 HYDROXYBUTYRATE DEHYDROGENASE EUDAMEDW0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Ketosure Poc by Apex Biotechnology Corp. — Class IVD General — 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-47136487609B06U | Class IVD General | 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 19562704-69b1-4aae-9984-348e51589e0d 61 fields · synced Jul 22, 2026
- EUDAMED b013d88c-43ef-435f-a951-d809ed31bdfd 61 fields · synced May 16, 2026