Identity
- Device Name
- Balloon Kyphoplasty Kits EUDAMED
- Model / Reference
- K05B EUDAMEDA500334 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974754671325 EUDAMED
- Basic UDI-DI
- B-06974754671325 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Balloon Kyphoplasty Kits by Beijing Bonsci Technology Co., Ltd. — Class IIa — 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-06974754671325 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Bonsci Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000013535
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ea8dfa90-36bc-4659-9dce-29da80cde15f 61 fields · synced Jun 18, 2026