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Emergency Backup Kit for the NOxBOXi system
EUDAMEDClass IIa (EU MDR)
Ref NOXKIT-EMER
Identity
- Trade Name
- Emergency Backup Kit for the NOxBOXi system EUDAMED
- Device Name
- NOxBOXi Consumable Kits EUDAMEDEmergency Backup Kit for the NOxBOXi system EUDAMED
- Model / Reference
- NOXKIT-EMER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060541640160 EUDAMED
- Basic UDI-DI
- 506054164NBiKITSMR EUDAMEDB-05060541640160 EUDAMED
- EMDN Code
- Z1203019002,Z1203019085 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDIreland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Emergency Backup Kit for the NOxBOXi system by NOxBOX Limited — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506054164NBiKITSMR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506054164NBiKITSMR | Class IIa | Active |
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Manufacturer
- Manufacturer
- NOxBOX Limited
- EUDAMED SRN
- GB-MF-000009734
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2ee2dfd8-d337-4052-a041-07295a7d622d 61 fields · synced Jul 16, 2026
- EUDAMED 99161d5f-585a-4aeb-92a8-256462c116c4 61 fields · synced May 17, 2026