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Me-Apds / Magentiq-Colo
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref APDS-DD-CU510(k) K252178
Identity
- Trade Name
- ME-APDS / MAGENTIQ-COLO EUDAMED
- Device Name
- ME-APDSTM (Magentiq Eye Automatic Polyp Detection System for Colonoscopies) / MAGENTIQ-COLOTM Automatic Polyp Detection System EUDAMED
- Model / Reference
- APDS-DD-CU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 7290020140029 EUDAMED
- Basic UDI-DI
- 7290020140DD-CUJX EUDAMED
- Direct Marketing DI
- 7290020140029 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I 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
Me-Apds / Magentiq-Colo by Magentiq Eye Ltd — 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
United States Active
FDA_510K
United States Active
FDA_510K
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 | K244023 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K223473 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K260724 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K252178 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7290020140DD-CUJX | Class I | Active |
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Manufacturer
- Manufacturer
- Magentiq Eye LTD
- EUDAMED SRN
- IL-MF-000011870
- FDA Applicant
- Magentiq Eye, Ltd.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 6f8c7949-d260-4c2f-ba52-b0ca545080df 85 fields · synced Jun 19, 2026
- FDA 510(k) K244023 1 fields · synced May 18, 2026