Identity
- Trade Name
- NP-350E EUDAMED
- Device Name
- NR-F350 EUDAMED
- Model / Reference
- NP-350E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800072300020 EUDAMED
- Basic UDI-DI
- 8800072301CA-1CB-1CC4Y EUDAMED
- Direct Marketing DI
- 08800072300020 EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Np-350e by Nanoray Co., Ltd — 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 | 8800072301CA-1CB-1CC4Y | Class IIb | Active |
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Manufacturer
- Manufacturer
- NANORAY Co., Ltd.
- EUDAMED SRN
- KR-MF-000017517
- Authorised Representative
- CALMED INVEST Kft. HU-AR-000006313
Sources (1)
- EUDAMED b55969ba-c034-4a2d-a497-8704ff9549cb 61 fields · synced Jun 18, 2026