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Balloon Kyphoplasty Kits
EUDAMEDClass IIa (EU MDR)
Ref A500339Model K07ARef A500301Model BP2040Ref A500322Model K02ARef A500330Model K04ARef A500300Model BP2030Ref A500326Model K03A
Identity
- Device Name
- Balloon Kyphoplasty Kits EUDAMED
- Model / Reference
- K07A EUDAMEDA500339 EUDAMEDBP2040 EUDAMEDA500301 EUDAMEDK02A EUDAMEDA500322 EUDAMEDK04A EUDAMEDA500330 EUDAMEDBP2030 EUDAMEDA500300 EUDAMEDK03A EUDAMEDA500326 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974754671370 EUDAMED06974754671172 EUDAMED06974754671202 EUDAMED06974754671288 EUDAMED06974754671165 EUDAMED06974754671240 EUDAMED
- Basic UDI-DI
- B-06974754671370 EUDAMEDB-06974754671172 EUDAMEDB-06974754671202 EUDAMEDB-06974754671288 EUDAMEDB-06974754671165 EUDAMEDB-06974754671240 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
Category: Joint prosthesis implantation kit, single-use
Balloon Kyphoplasty Kits by Beijing Bonsci Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06974754671370 | 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 (6)
- EUDAMED 03d12db3-4d56-43bd-bc78-15b1359b4bdf 61 fields · synced Sep 17, 2026
- EUDAMED aaa2f428-da94-464a-8bd5-7f724868a346 61 fields · synced May 17, 2026
- EUDAMED 1fdb9437-3931-43cb-8c86-d09d70d4250d 61 fields · synced May 17, 2026
- EUDAMED cab149d8-ac9f-4ce7-b9eb-29645b1ec62e 61 fields · synced May 18, 2026
- EUDAMED 695597c8-cf9d-4da0-b725-e20fd5f2d172 61 fields · synced May 19, 2026
- EUDAMED 0cb60625-b74e-4973-b9be-de0a8070f213 61 fields · synced May 19, 2026