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Z1 QTube/Silencer
EUDAMEDClass I (EU MDR)
Ref 005997Model Class I Ventilator Accessories
Identity
- Trade Name
- Z1 QTube/Silencer EUDAMED
- Model / Reference
- Class I Ventilator Accessories EUDAMED005997 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820059973 EUDAMED
- Basic UDI-DI
- 7321820139999H EUDAMED
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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 QTube/Silencer by Breas Medical AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7321820139999H | Class I | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (1)
- EUDAMED 35ff8e0c-851f-4a61-854f-6b3e0837685a 61 fields · synced Jul 9, 2026