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Concentriq AP-Dx
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref Concentriq DxModel Concentriq AP-DxRef DX040GL
Identity
- Trade Name
- Concentriq AP-Dx EUDAMED
- Device Name
- Concentriq AP-Dx EUDAMED
- Model / Reference
- Concentriq AP-Dx EUDAMEDConcentriq Dx EUDAMEDDX040GL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860006054526 EUDAMED00860006054588 EUDAMED
- Basic UDI-DI
- 0860006054526R7 EUDAMED
- Direct Marketing DI
- 00860006054526 EUDAMED00860006054588 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
- Sweden EUDAMEDAustria 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
EUDAMEDEUDAMED
Concentriq AP-Dx by Proscia, Inc. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230839 | Class A | Active |
| 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 (3)
- EUDAMED a3cf2f17-7074-4996-a6aa-96d99032f5e2 61 fields · synced Jul 12, 2026
- EUDAMED 9d1c8667-1461-46c1-84be-332d5cc440c0 61 fields · synced May 19, 2026
- FDA 510(k) K230839 1 fields · synced May 18, 2026