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NOxFLOW sensor for use with NOxBOXi system
EUDAMEDClass IIa (EU MDR)
Ref NOXFLOW-2
Identity
- Trade Name
- NOxFLOW sensor for use with NOxBOXi system EUDAMED
- Device Name
- NOxFLOW sensor for use with NOxBOXi system EUDAMEDNOxBOXi Consumable Kits EUDAMED
- Model / Reference
- NOXFLOW-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060541640092 EUDAMED
- Basic UDI-DI
- B-05060541640092 EUDAMED506054164NBiKITSMR EUDAMED
- EMDN Code
- Z1203019002,Z1203019085 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDNorthern 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NOxFLOW sensor for use with NOxBOXi system by NOxBOX Limited — Class IIa — 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-05060541640092 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060541640092 | 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 e093eb9a-acd0-4ce8-a166-f5ea088dea5e 61 fields · synced Jul 12, 2026
- EUDAMED fa423251-ab1c-4135-97d1-8a37cbc79640 61 fields · synced May 17, 2026