Identity
- Trade Name
- NOxBOXi EUDAMED
- Device Name
- NOxBOXi Nitric Oxide Delivery and Monitoring System EUDAMED
- Model / Reference
- NOXBOX-I, NOXDC-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060541640009 EUDAMED
- Basic UDI-DI
- B-05060541640009 EUDAMED506054164NBiFB EUDAMED
- Direct Marketing DI
- 05060541640009 EUDAMED
- EMDN Code
- Z1203019002 NITRIC OXIDE DISPENSERS EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NOxBOXi by NOxBOX Limited — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060541640009 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05060541640009 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NOxBOX Limited
- EUDAMED SRN
- GB-MF-000009734
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED d4ca06cc-0c3a-473d-b6b1-7effb0389d02 61 fields · synced Jun 18, 2026
- EUDAMED 391f81b1-3c49-416c-8f7f-377bfa57d61c 61 fields · synced May 17, 2026
- EUDAMED d4ca06cc-0c3a-473d-b6b1-7effb0389d02-1 61 fields · synced Jun 9, 2026
- EUDAMED 391f81b1-3c49-416c-8f7f-377bfa57d61c-1 61 fields · synced Jun 10, 2026