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Bone Filler Device
EUDAMEDClass IIa (EU MDR)
Ref FG2504Model FG2500, FG2501, FG2502, FG2503, FG2504, FG2505, KMC-013-00, KMC-013-01, KMC-013-10, KMC-014-00, KMC-015-00, KMC-016-00
Identity
- Device Name
- Bone Filler Device EUDAMED
- Model / Reference
- FG2500, FG2501, FG2502, FG2503, FG2504, FG2505, KMC-013-00, KMC-013-01, KMC-013-10, KMC-014-00, KMC-015-00, KMC-016-00 EUDAMEDFG2504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938695525048 EUDAMED
- Basic UDI-DI
- 69386955BFJV EUDAMED
- Direct Marketing DI
- 06938695525048 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
Bone Filler Device 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 | 69386955BFJV | 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 (1)
- EUDAMED 1b08379c-a19f-42a9-a399-bfed6fcbd3ed 61 fields · synced Oct 5, 2026