Identity
- Trade Name
- QualiBreath (size XXL) EUDAMED
- Device Name
- QualiBreath EUDAMED
- Model / Reference
- QualiBreath EUDAMEDQB-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033675190068 EUDAMED
- Basic UDI-DI
- 803367519QB00B9 EUDAMED
- EMDN Code
- Y060307 THORACIC ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
QualiBreath (size XXL) by Qualiteam s.r.l. — 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 | 803367519QB00B9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qualiteam s.r.l.
- EUDAMED SRN
- IT-MF-000026616
Sources (1)
- EUDAMED 793d1ecd-da6f-4200-b82a-48222e139fb0 61 fields · synced Jul 30, 2026