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Z1 Slim-Style CPAP Tube
EUDAMEDClass IIa (EU MDR)
Ref 005797Model Patient circuitsModel Patient circuits (Non-heated)
Identity
- Trade Name
- Z1 Slim-Style CPAP Tube EUDAMEDZ1 Slim Style CPAP Tube EUDAMED
- Device Name
- Z1 Slim Style CPAP Tube EUDAMEDPatient circuits (Non-heated) EUDAMED
- Model / Reference
- Patient circuits EUDAMED005797 EUDAMEDPatient circuits (Non-heated) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820057979 EUDAMED
- Basic UDI-DI
- B-07321820057979 EUDAMED7321820109998U EUDAMED
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Z1 Slim-Style CPAP Tube by Breas Medical AB — 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-07321820057979 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07321820057979 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (2)
- EUDAMED 0ffe909d-0e45-4e8e-b196-3fcd32ece92d 61 fields · synced Jul 9, 2026
- EUDAMED d92baf91-4eb1-401e-8704-9478f46ab20d 61 fields · synced May 19, 2026