Identity
- Trade Name
- StoneChecker EUDAMED
- Device Name
- StoneChecker EUDAMED
- Model / Reference
- StoneChecker EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-B319STONECHECKER11ED EUDAMED
- Basic UDI-DI
- B-B319STONECHECKER11ED EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
StoneChecker by Imaging Biometrics, LLC — Class I — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191530 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-B319STONECHECKER11ED | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imaging Biometrics, LLC
- EUDAMED SRN
- US-MF-000033700
- Authorised Representative
- Casus Consulting Limited IE-AR-000023507
Sources (2)
- EUDAMED 77520b51-5c7f-479a-8b03-5e5e166d90b8 61 fields · synced Jul 30, 2026
- FDA 510(k) K191530 1 fields · synced May 18, 2026