Identity
- Device Name
- Accusay Mono EUDAMED
- Model / Reference
- ACC-M001P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10743816001522 EUDAMED
- Basic UDI-DI
- B-10743816001522 EUDAMED
- EMDN Code
- W0105040403 EBV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Accusay Mono by Princeton Biomeditech 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-10743816001522 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Princeton BioMeditech Corporation
- EUDAMED SRN
- US-MF-000048310
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 3ae1f8f7-8af4-4889-8fb8-f3a63b3e05cc 61 fields · synced Jun 19, 2026