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Kyphoplasty Multifunctional Tool
EUDAMEDClass IIa (EU MDR)
Ref FG5100Model FG5100, FG5101, FG5110, FG5102, FG5103, FG5111, FG5200, FG5201, FG5202, FG5203, FG5210, FG5300, FG5301, FG5302, FG5303, FG5310, KMC-018-00, KMC-018-01Ref FG5101
Identity
- Trade Name
- Kyphoplasty Multifunctional Tool EUDAMED
- Device Name
- Kyphoplasty Multifunctional Tool EUDAMED
- Model / Reference
- FG5100, FG5101, FG5110, FG5102, FG5103, FG5111, FG5200, FG5201, FG5202, FG5203, FG5210, FG5300, FG5301, FG5302, FG5303, FG5310, KMC-018-00, KMC-018-01 EUDAMEDFG5100 EUDAMEDFG5101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938695550026 EUDAMED06938695551016 EUDAMED
- Basic UDI-DI
- 69386955BAJK EUDAMED
- Direct Marketing DI
- 06938695550026 EUDAMED06938695551016 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Kyphoplasty Multifunctional Tool by Shanghai Kinetic Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69386955BAJK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017688
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED fe5f3479-bff6-4ec5-b48f-2661c4badfcc 61 fields · synced Oct 7, 2026
- EUDAMED 25a374c2-dc42-4b22-9a99-3aaaa03ce36c 61 fields · synced May 16, 2026