Identity
- Trade Name
- neos EUDAMED
- Device Name
- neos EUDAMED
- Model / Reference
- NEOS-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649989541017 EUDAMED
- Basic UDI-DI
- 7649989541-neos-0XX-F5 EUDAMED
- Direct Marketing DI
- 07649989541017 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
neos by machineMD AG — Class IIa — 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 | 7649989541-neos-0XX-F5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- machineMD AG
- EUDAMED SRN
- CH-MF-000041378
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (1)
- EUDAMED 1dc4ded9-a71f-4d7b-bf32-dc5c0b60fe2d 61 fields · synced Jun 19, 2026