Identity
- Trade Name
- CARPL EUDAMED
- Device Name
- CARPL EUDAMED
- Model / Reference
- CARPL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860015443526 EUDAMED00860012916306 EUDAMED
- Basic UDI-DI
- 8600129163V2CF EUDAMED
- Direct Marketing DI
- 00860015443526 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Carpl by CARPL.ai Inc. — Class I — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232891 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8600129163V2CF | Class I | Active |
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Manufacturer
- Manufacturer
- CARPL.ai Inc.
- EUDAMED SRN
- US-MF-000044270
- Authorised Representative
- Freyr Life Sciences GmbH DE-AR-000021795
Sources (3)
- EUDAMED 2bd5a7e2-d3ba-47f0-8680-1799b131da9e 61 fields · synced Jul 23, 2026
- EUDAMED d7ad9b2e-34b7-4f7a-a2e9-17c589bb1a51 61 fields · synced May 19, 2026
- FDA 510(k) K232891 1 fields · synced May 18, 2026