Identity
- Trade Name
- Concentriq AP-Dx-OUS EUDAMED
- Device Name
- Concentriq AP-Dx EUDAMED
- Model / Reference
- Concentriq AP-Dx EUDAMEDOUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860006054533 EUDAMED
- Basic UDI-DI
- 0860006054526R7 EUDAMED
- Direct Marketing DI
- 00860006054533 EUDAMED
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
New Device
Yes
EUDAMED
Concentriq AP-Dx-OUS by Proscia, Inc. — 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 | 0860006054526R7 | Class A | Active |
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Manufacturer
- Manufacturer
- Proscia, Inc.
- EUDAMED SRN
- US-MF-000027154
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6c5b16d6-efb8-4eff-b1ae-2ae8a989b1f5 61 fields · synced Jul 20, 2026