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Bone Cement Injection Gun
EUDAMEDFDA UDIClass I (EU MDR)
Ref SD8101Model SD8101, SD8102, SD8103
Identity
- Trade Name
- Bone Cement Injection Gun FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Bone Cement Injection Gun EUDAMEDFDA UDI
- Model / Reference
- SD8101, SD8102, SD8103 EUDAMEDSD8101 EUDAMEDFDA UDI
- Description
- Bone Cement Injection Gun FDA UDI
Identifiers
- Catalog Number
- SD8101 FDA UDI
- Primary DI / UDI-DI
- 06938695501295 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955SDLC EUDAMED
- Direct Marketing DI
- 06938695501295 EUDAMED
- FDA Product Code
- KIH FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bone Cement Injection Gun by Shanghai Kinetic Medical Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69386955SDLC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 443e3780-016e-46ca-8f0d-947d4ccbad32 61 fields · synced Oct 6, 2026
- FDA UDI 43d4677f-f4c3-4a6e-b78e-f6b71d410181 36 fields · synced May 30, 2026