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Balloon Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FG1001-15Model FG1001-10, FG1001-15, FG1001-20, FG1101-10,FG1101-15, FG1101-20, FG1010, FG1015, FG1020, FG1025, FG1030, FA1010, FA1015, FA1020, FA1025, FA1030, SS101-2010, SS101-2015, SS101-2020, KMC-003-10, KMC-003-15, KMC-003-20, KMC-004-10, KMC-004-15, KMC-004-20
Identity
- Trade Name
- Balloon Catheter FDA UDI
- Generic Name
- Inflatable bone tamp FDA UDI
- Device Name
- Balloon Catheter EUDAMEDKMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI
- Model / Reference
- FG1001-10, FG1001-15, FG1001-20, FG1101-10,FG1101-15, FG1101-20, FG1010, FG1015, FG1020, FG1025, FG1030, FA1010, FA1015, FA1020, FA1025, FA1030, SS101-2010, SS101-2015, SS101-2020, KMC-003-10, KMC-003-15, KMC-003-20, KMC-004-10, KMC-004-15, KMC-004-20 EUDAMEDFG1001-15 EUDAMEDFDA UDI
- Description
- KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI
Identifiers
- Catalog Number
- FG1001-15 FDA UDI
- Primary DI / UDI-DI
- 06938695510150 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955BIK3 EUDAMED
- Direct Marketing DI
- 06938695510150 EUDAMED
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- HRX FDA UDINDN FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Inflatable bone tamp FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI888.3027 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Millimeter FDA UDI
Balloon Catheter by Shanghai Kinetic Medical Co., Ltd. — Class IIa — 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 | 69386955BIK3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 97f84b77-1dec-4a4a-b3ec-3d974fa25037 61 fields · synced Jun 8, 2026
- FDA UDI 2c549081-9f15-483f-b4c9-1ca509b76e1c 38 fields · synced May 30, 2026