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Bb Respirator
EUDAMEDClass IIb (EU MDR)
Ref LUNA BELTModel Luna BeltRef BBRModel BB Respirator
Identity
- Trade Name
- BB RESPIRATOR EUDAMED
- Device Name
- Luna Belt EUDAMEDBB Respirator EUDAMED
- Model / Reference
- Luna Belt EUDAMEDBB Respirator EUDAMEDBBR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058647920122 EUDAMED08058647920115 EUDAMED
- Basic UDI-DI
- B-08058647920122 EUDAMEDB-08058647920115 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Bb Respirator by Dima Italia S.r.l. — Class IIb — 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-08058647920122 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dima Italia S.r.l.
- EUDAMED SRN
- IT-MF-000020327
Sources (2)
- EUDAMED 6f9b61e3-9f55-466c-a3a2-ac4f3e402385 61 fields · synced Sep 18, 2026
- EUDAMED 59e367c9-3bfc-4a57-9bd6-f5a23104ca3b 61 fields · synced May 18, 2026