Identity
- Trade Name
- Z1 Auto EUDAMED
- Device Name
- Z1 Auto EUDAMED
- Model / Reference
- Z1 Auto-CPAP EUDAMED218000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321822180002 EUDAMED
- Basic UDI-DI
- B-07321822180002 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT 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
Z1 Auto 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-07321822180002 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (1)
- EUDAMED 4242c21f-d070-4abd-b54d-5fafdbefbf4b 61 fields · synced Jul 9, 2026