Identity
- Trade Name
- OSTEOPLASTY BALLOON EUDAMED
- Device Name
- SYSTEMS FOR METAPHYSEAL FRACTURES EUDAMEDOSTEOPLASTY BALLOON EUDAMED
- Model / Reference
- TBPBAL15J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860036034 EUDAMED
- Basic UDI-DI
- 8033860OSTEOFT01CDE EUDAMEDB-08033860036034 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
The OSTEOPLASTY BALLOON is a medical device used in the treatment of fractures, particularly those occurring in the metaphyseal region. This balloon has undergone extensive testing and evaluation to ensure its safety and efficacy.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860OSTEOFT01CDE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860OSTEOFT01CDE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 2cbe1e33-3221-4ecf-87a0-4cdace7cb0ad 61 fields · synced Jul 14, 2026
- EUDAMED f0ef3d1c-141b-4500-86c9-84ba39346c3e 61 fields · synced Jun 18, 2026