← Back to catalogue
Contrex Plus 6
EUDAMEDClass IVD General (EU MDR)
Ref S5800403 S5800404 S5800405
Identity
- Trade Name
- Contrex Plus 6 EUDAMED
- Device Name
- Contrex Plus 6 Glucose Control Solution EUDAMED
- Model / Reference
- S5800403 S5800404 S5800405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487603B1SXQ EUDAMED
- Basic UDI-DI
- B-47136487603B1SXQ EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Contrex Plus 6 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-47136487603B1SXQ | Class IVD General | 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 3257515d-42ae-4663-9684-57f24df49576 61 fields · synced Jun 19, 2026