Identity
- Device Name
- Genki Edge EUDAMED
- Model / Reference
- DeepTek_004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908023670021 EUDAMED
- Basic UDI-DI
- 8908023670DT0042M 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
- Ireland 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
Genki Edge by Deeptek Medical Imaging Private Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8908023670DT0042M | Class I | Active |
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Manufacturer
- Manufacturer
- DeepTek Medical Imaging Private Limited
- EUDAMED SRN
- IN-MF-000040297
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (1)
- EUDAMED 94339f77-ddb1-40fa-85c5-860b76d7c7b3 61 fields · synced Jul 29, 2026