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Medical Balloon Catheter Syringe Pump
EUDAMEDFDA UDIClass I (EU MDR)
Ref FG4001Model FG4001, FG4003, FG4002, FG4004, FG4005, FG4006, KMC-006-01, KMC-006-02
Identity
- Trade Name
- KMC Medical Balloon Catheter Syringe Pump FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Medical Balloon Catheter Syringe Pump EUDAMEDKMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI
- Model / Reference
- FG4001, FG4003, FG4002, FG4004, FG4005, FG4006, KMC-006-01, KMC-006-02 EUDAMEDFG4001 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
- Primary DI / UDI-DI
- 06938695540010 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955SPM4 EUDAMED
- Direct Marketing DI
- 06938695540010 EUDAMED
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- NDN FDA UDIHRX FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.1100 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
Yes
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 — 30 Centimeter FDA UDIPressure — 440 Pound per Square Inch FDA UDI
Medical Balloon Catheter Syringe Pump by Shanghai Kinetic Medical Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69386955SPM4 | 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 9810daff-37da-443c-bbfb-7a50bdfe1ab2 61 fields · synced Oct 7, 2026
- FDA UDI f9966ab8-cce6-4c8a-8412-22cd38d012c0 36 fields · synced May 30, 2026