Identity
- Trade Name
- Nitelog EUDAMED
- Device Name
- Z1 Mobile App (Nitelog) EUDAMED
- Model / Reference
- Z1 Mobile App (Nitelog) EUDAMED006003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820060030 EUDAMED
- Basic UDI-DI
- B-07321820060030 EUDAMED
- EMDN Code
- Z1203019082 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nitelog by Breas Medical AB — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07321820060030 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (1)
- EUDAMED 22e7a2cb-a39c-4d7a-9dc4-78a65fdb6937 61 fields · synced Oct 6, 2026