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Shanghai Kinetic Medical Co., Ltd.

China·CN-MF-000017688

Last updated May 27, 2026

What Shanghai Kinetic Medical Co., Ltd. makes

Shanghai Kinetic Medical Co., Ltd. manufactures bone access channel kits, balloon kyphoplasty kits, inflatable bone tamps, orthopaedic cement preparation and delivery kits, bone grafting cannulas, and single-use balloon inflators. The company also produces periodontal disease-associated nucleic acid test kits and various surgical instruments including drills, guide wires, access needles, and balloon catheters.

The company is based in China, and its device portfolio is categorized under Class I, Class II, and Class IIa regulatory classifications. These products are listed in the EUDAMED database, the FDA 510(k) clearance database, and the FDA UDI database.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Shanghai Kinetic Medical Co., Ltd. manufacture?

Shanghai Kinetic Medical Co., Ltd. produces a range of orthopaedic and surgical equipment. Their primary offerings include bone access channel kits, balloon kyphoplasty kits, inflatable bone tamps, orthopaedic cement preparation and delivery kits, bone grafting cannulas, and single-use balloon inflators. Additionally, they manufacture surgical instruments such as drills, guide wires, access needles, balloon catheters, and periodontal disease-associated nucleic acid test kits.

Where is Shanghai Kinetic Medical Co., Ltd. located?

Shanghai Kinetic Medical Co., Ltd. is based in China. This location information is provided based on the company's official registration data, which identifies the country of origin as CN.

How are the devices from Shanghai Kinetic Medical Co., Ltd. classified?

The devices manufactured by Shanghai Kinetic Medical Co., Ltd. are categorized under Class I, Class II, and Class IIa regulatory classifications. These classifications reflect the varying levels of risk and regulatory requirements associated with the specific medical devices in their product portfolio.

Which regulatory registries list the devices from Shanghai Kinetic Medical Co., Ltd.?

The devices produced by Shanghai Kinetic Medical Co., Ltd. are listed in the EUDAMED database, the FDA 510(k) clearance database, and the FDA UDI database. These listings indicate that the company's products are tracked within these specific international and national regulatory systems.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: China
Address: 2F, No. 23 Building, 528 Ruiqing Rd., East Zhangjiang High-Tech Park, Pudong, Shanghai, China
Website: shkmc.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +862150720558
PRRC Contact: —
EUDAMED SRN: CN-MF-000017688
FDA FEI Number: —
DUNS Number: 528198569

Catalogue (151)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
KMC OneShot Single Balloon Assembly, 8 Gauge, 20mm	KMCA-201-20	FDA UDI	Class II	Active
Balloon Catheter Curved	LC10225	FDA UDI	Class II	Active
KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel Tip	KMC-001-30	FDA UDI	Class II	Active
Bone Filler Device	FG2510	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8110	FDA UDI	Class I	Active
KMC Bone Filler Device, 10 Gauge, Flat Tip	KMC-014-00	FDA UDI	Class II	Active
KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm	KMCA-301-10	FDA UDI	Class II	Active
KMC Balloon Catheter, 10 Gauge, 20mm	KMC-004-20	FDA UDI	Class II	Active
KMC Multipurpose Tool, 7 Gauge, 16/14mm	KMC-018-00	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8215	FDA UDI	Class I	Active
Curved Curette	VO1113	FDA UDI	Class I	Active
Balloon Catheter Syringe Pump	FG4011	FDA UDI	Class II	Active
KMC Biopsy Device, 8 Gauge, Square Tip	KMC-015-10	FDA UDI	Class II	Active
KMC Vertebral Osteotome	VO1101	FDA UDI	Class I	Active
KMC Single Balloon Assembly, 8 Gauge, 20mm	KMCA-101-20	FDA UDI	Class II	Active
Curette	FG9011	FDA UDI	Class I	Active
Balloon Catheter Curved	LC10220	FDA UDI	Class II	Active
KMC Balloon Catheter Curved, 10 Gauge, 45°, 15mm	KMC-005-15	FDA UDI	Class II	Active
Balloon Catheter Syringe Pump	FG4013	FDA UDI	Class II	Active
KMC Curved Curette	KMC-017-10	FDA UDI	Class II	Active
KMC OneShot Working Channel, 10 Gauge, Bevel Tip	KMC-010-02	FDA UDI	Class II	Active
Bone Biopsy Device	BC1111	FDA UDI	Class I	Active
KMC Vertebral Osteotome	VO1105	FDA UDI	Class I	Active
KMC Drill, 8 Gauge, 200mm	KMC-011-00	FDA UDI	Class II	Active
KMC Single Balloon Assembly, 8 Gauge, 15mm	KMCA-101-15	FDA UDI	Class II	Active
KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel Tip	KMC-002-10	FDA UDI	Class II	Active
KMC Vertebral Ostetome	VO1106	FDA UDI	Class I	Active
KMC Balloon Catheter, 10 Gauge, 15mm	KMC-004-15	FDA UDI	Class II	Active
Multifunctional Tool	FG5400	FDA UDI	Class II	Active
Access Needle	FG3018	FDA UDI	Class II	Active
One-Shot	FG2710	FDA UDI	Class I	Active
KMC Guide Wire, 1.6mm, Blunt Tip	KMC-000-00	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8315	FDA UDI	Class I	Active
KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip	KMC-001-11	FDA UDI	Class II	Active
Bone Filler Device	FG2513	FDA UDI	Class II	Active
KMC Double Balloon Assembly, 8 Gauge, 20mm	KMCA-100-20	FDA UDI	Class II	Active
KMC Vertebral Osteotome	VO1104	FDA UDI	Class I	Active
KMC Bone Filler Device, 8 Gauge, Lateral Open Tip	KMC-013-10	FDA UDI	Class II	Active
KMC Balloon Catheter Curved, 10 Gauge, 45°, 25mm	KMC-005-25	FDA UDI	Class II	Active
KMC Biopsy Device, 10 Gauge, Trephine Tip	KMC-016-00	FDA UDI	Class II	Active
KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip	KMC-001-10	FDA UDI	Class II	Active
KMC Access Needle, 13 Gauge, 115mm, Pyramid Tip	KMC-002-01	FDA UDI	Class II	Active
KMC Balloon Catheter, 8 Gauge, 20mm	KMC-003-20	FDA UDI	Class II	Active
KMC OneShot Single Balloon Assembly, 10 Gauge, 20mm	KMCA-301-20	FDA UDI	Class II	Active
KMC OneShot Double Balloon Assembly, 8 Gauge, 15mm	KMCA-200-15	FDA UDI	Class II	Active
KMC Balloon Catheter Curved, 10 Gauge, 45°, 20mm	KMC-005-20	FDA UDI	Class II	Active
KMC Double Balloon Assembly, 8 Gauge, 15mm	KMCA-100-15	FDA UDI	Class II	Active
KMC Bone Filler Device, 8 Gauge, Flat Tip	KMC-013-01	FDA UDI	Class II	Active
KMC OneShot Double Balloon Assembly, 8 Gauge, 10mm	KMCA-200-10	FDA UDI	Class II	Active
Puncture Needle	FG3005	EUDAMEDFDA UDI	Class IIa	Active

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