Identity
- Device Name
- CPAP BREATHING BAG EUDAMED
- Model / Reference
- STARBALL EUDAMEDSB25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323015944 EUDAMED
- Basic UDI-DI
- 80583230DCPALLONI6X EUDAMED
- Direct Marketing DI
- 08058323015944 EUDAMED
- EMDN Code
- R03020102 CPAP BALLOONS EUDAMED
Classification
- Device Class
- Class IIa 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
Cpap Breathing Bag by Intersurgical SpA — Class IIa — 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 | 80583230DCPALLONI6X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED be3b8ea8-2392-4a0a-9ae3-fd167e8969dd 61 fields · synced Jun 18, 2026