Identity
- Trade Name
- Dr.Noon EUDAMED
- Device Name
- DrNoon EUDAMED
- Model / Reference
- DrNoon EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800118000051 EUDAMED
- Basic UDI-DI
- B-08800118000051 EUDAMED
- EMDN Code
- Z129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Poland 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
Dr.Noon by Mediwhale, Inc — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800118000051 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mediwhale, Inc
- EUDAMED SRN
- KR-MF-000011626
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED a53a2f17-753d-4c48-9bcd-ddb0d8065928 61 fields · synced Jun 19, 2026