Identity
- Trade Name
- KETOSURE POC EUDAMED
- Device Name
- KETOSURE POC Blood Ketone Monitoring System EUDAMED
- Model / Reference
- M032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713648764574 EUDAMED
- Basic UDI-DI
- 47136487607B00KMbYP EUDAMED
- EMDN Code
- W020106019099 VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Ketosure Poc by Apex Biotechnology Corp. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 47136487607B00KMbYP | Class A | 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 (1)
- EUDAMED e6bf87b1-2314-4eda-9b52-b1668fd16112 61 fields · synced Jun 19, 2026