Identity
- Device Name
- pcr.ai API EUDAMED
- Model / Reference
- PCR-AI-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290020318008 EUDAMED
- Basic UDI-DI
- 7290020318AIB4 EUDAMED
- Direct Marketing DI
- 07290020318008 EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
pcr.ai API by Azure Vault Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7290020318AIB4 | Class A | Active |
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Manufacturer
- Manufacturer
- Azure Vault Ltd
- EUDAMED SRN
- IL-MF-000047316
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 3d37a33b-deb6-49bb-8d24-dc8a52354260 61 fields · synced Aug 4, 2026