Identity
- Trade Name
- Max 30 EUDAMED
- Device Name
- Nidek Medical Oxygen Concentrators EUDAMED
- Model / Reference
- 3005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00038214001636 EUDAMED
- Basic UDI-DI
- 00038214NIDEK4L EUDAMED
- Direct Marketing DI
- 00038214001636 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Max 30 by Nidek Medical Products Inc. — Class IIb — 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 | 00038214NIDEK4L | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- EUDAMED SRN
- US-MF-000007253
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 549e1f91-9bfb-4c1a-82b7-fb21e28ea7b9 61 fields · synced Jun 18, 2026