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Contrex Plus 5
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref S5800301 S5800303 S5800459 S5800460 S5800461
Identity
- Trade Name
- Contrex Plus 5 EUDAMED
- Device Name
- Contrex Plus 5 Glucose Control Solution EUDAMED
- Model / Reference
- S5800301 S5800303 S5800459 S5800460 S5800461 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487603C1SXV EUDAMED
- Basic UDI-DI
- B-47136487603C1SXV EUDAMED
- EMDN Code
- W010106010801 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Contrex Plus 5 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-47136487603C1SXV | 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 (1)
- EUDAMED ecf83157-f086-48ae-a595-82780be67bf7 61 fields · synced Jun 18, 2026