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Bone Filler Device
EUDAMEDClass IIa (EU MDR)
Ref FG2502Model FG2500, FG2501, FG2502, FG2503, FG2504, FG2505, KMC-013-00, KMC-013-01, KMC-013-10, KMC-014-00, KMC-015-00, KMC-016-00Ref FG2505
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 EUDAMEDFG2502 EUDAMEDFG2505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938695525024 EUDAMED06938695552495 EUDAMED
- Basic UDI-DI
- 69386955BFJV EUDAMED
- Direct Marketing DI
- 06938695525024 EUDAMED06938695552495 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 (2)
- EUDAMED fcb2e28a-b9d4-4cc2-925b-b1afb4ab1b5e 61 fields · synced Oct 6, 2026
- EUDAMED 15aab3be-a906-4a5d-95f0-3db64ebf8cae 61 fields · synced May 18, 2026