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Artron Fecal Occult Blood (FOB)Test
EUDAMEDClass IVD General (EU MDR)
Ref A05-02-422Model cassette
Identity
- Trade Name
- Artron Fecal Occult Blood (FOB)Test EUDAMED
- Device Name
- Fecal Occult Blood (FOB)Test EUDAMED
- Model / Reference
- cassette EUDAMEDA05-02-422 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347564094 EUDAMED
- Basic UDI-DI
- B-00628347564094 EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Artron Fecal Occult Blood (FOB)Test by Artron Laboratories Inc. — 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-00628347564094 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 24f134bf-baaf-49c3-b574-18af4162d5a1 61 fields · synced Oct 6, 2026