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BioProtect Balloon Implant System
EUDAMEDClass III (EU MDR)
Ref 0135
by BioProtect
Identity
- Trade Name
- BioProtect Balloon Implant System EUDAMED
- Device Name
- Bioprotect Balloon Implant System EUDAMED
- Model / Reference
- 0135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290014878013 EUDAMED
- Basic UDI-DI
- 7290014878BP0135V3 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Category: Device sterilization/disinfection container, reusable
BioProtect Balloon Implant System by BioProtect — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7290014878BP0135V3 | Class III | Active |
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Manufacturer
- Manufacturer
- BioProtect
- EUDAMED SRN
- IL-MF-000013165
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 91d5e31d-fc71-4aa0-bc26-15e34920a810 61 fields · synced Jun 18, 2026