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PPX Rapid Test Cassette (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref DPP-R402
Identity
- Trade Name
- PPX Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- PPX Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- DPP-R402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DPP-R402(ACRO)6P EUDAMED
- Basic UDI-DI
- B-DPP-R402(ACRO)6P EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
PPX Rapid Test Cassette (Whole Blood +2 more) by ACRO BIOTECH Inc. — Class IVD General — IVDD — listed in EUDAMED — 3 models — 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-DPP-R402(ACRO)6P | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Acro Biotech Inc.
- EUDAMED SRN
- US-MF-000017832
- Authorised Representative
- VidaQuick Biotech S.L. ES-AR-000048138
Sources (1)
- EUDAMED 877c86e2-4920-4f30-bab7-920954ad8389 61 fields · synced Sep 17, 2026