Identity
- Trade Name
- KETOSURE POC EUDAMED
- Device Name
- KETOSURE POC Ketone Control Solution EUDAMED
- Model / Reference
- S5800358 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487609BKS3G EUDAMED
- Basic UDI-DI
- B-47136487609BKS3G EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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-47136487609BKS3G | 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 (1)
- EUDAMED e737847a-f292-4666-8f67-8cfa9929c271 61 fields · synced Jun 19, 2026