Balloon Kyphoplasty Kit
by Stryker Trauson (Changzhou) Medical Technology Co., Ltd. 19 variants
Ref 13803100EModel Puncture Needle
Withdrawn
CE MDD, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06931720407883 06931720407883 | Date16 Aug 2026 | StatusWithdrawn |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Withdrawn
Specification
- Device Name
- Puncture Needle
- Model / Reference
- Puncture Needle, 13803100E
- Primary DI / UDI-DI
- 06931720407883
- Basic UDI-DI
- B-06931720407883
- EMDN Code
- A019011 Intraosseous infusion and vertebroplasty infusion needles and kits
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- CN-MF-000005689
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No