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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 (147)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Balloon Catheter	FA1110	FDA UDI	Class II	Active
Bone Filler Device	FG2512	FDA UDI	Class II	Active
KMC Multipurpose Tool, 7 Gauge, 22/23mm	KMC-018-01	FDA UDI	Class II	Active
Drill	FG2110	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8210	FDA UDI	Class I	Active
KMC Inflation Syringe, 60cm, 30atm	KMC-006-02	FDA UDI	Class II	Active
KMC OneShot Single Balloon Assembly, 10 Gauge, 15mm	KMCA-301-15	FDA UDI	Class II	Active
Drill	FG2111	FDA UDI	Class II	Active
KMC Access Needle, 11 Gauge, 95mm, Bevel Tip	KMC-001-00	FDA UDI	Class II	Active
KMC OneShot Working Channel, 10 Gauge, Pyramid Tip	KMC-010-03	FDA UDI	Class II	Active
Multifunctional Tool	FG5401	FDA UDI	Class II	Active
KMC Guide Wire, 1.6mm, Sharp Tip	KMC-000-10	FDA UDI	Class II	Active
KMC Curette	KMC-017-00	FDA UDI	Class II	Active
KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm	KMCA-201-10	FDA UDI	Class II	Active
Balloon Catheter	FA1120	FDA UDI	Class II	Active
KMC Single Balloon Assembly, 8 Gauge, 10mm	KMCA-101-10	FDA UDI	Class II	Active
KMC Working Channel, 8 Gauge	KMC-008-00	FDA UDI	Class II	Active
Access Needle	FG3016	FDA UDI	Class II	Active
KMC Inflation Syringe, 30cm, 30atm	KMC-006-01	FDA UDI	Class II	Active
KMC Vertebral Osteotome	VO1102	FDA UDI	Class I	Active
KMC Drill, 8 Gauge, 220mm	KMC-011-01	FDA UDI	Class II	Active
KMC OneShot Double Balloon Assembly, 10 Gauge, 15mm	KMCA-300-15	FDA UDI	Class II	Active
KMC OneShot Working Channel, 8 Gauge, Bevel Tip	KMC-010-00	FDA UDI	Class II	Active
Dilator w/Cannula	FG2410	FDA UDI	Class II	Active
KMC Double Balloon Assembly, 8 Gauge, 10mm	KMCA-100-10	FDA UDI	Class II	Active
Balloon Catheter Curved	LC10215	FDA UDI	Class II	Active
KMC Balloon Catheter, 8 Gauge, 10mm	KMC-003-10	FDA UDI	Class II	Active
Balloon Catheter	FA1115	FDA UDI	Class II	Active
KMC OneShot Double Balloon Assembly, 10 Gauge, 20mm	KMCA-300-20	FDA UDI	Class II	Active
KMC OneShot Double Balloon Assembly, 10 Gauge, 10mm	KMCA-300-10	FDA UDI	Class II	Active
KMC Access Needle, 13 Gauge, 95mm, Pyramid Tip	KMC-002-00	FDA UDI	Class II	Active
Access Needle	FG3019	FDA UDI	Class II	Active
KMC Bone Filler Device, 8 Gauge, Bevel Tip	KMC-013-00	FDA UDI	Class II	Active
Cannula	FG2210	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8108	FDA UDI	Class I	Active
KMC OneShot Working Channel, 8 Gauge, Pyramid Tip	KMC-010-01	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8310	FDA UDI	Class I	Active
KMC Balloon Catheter, 10 Gauge, 10mm	KMC-004-10	FDA UDI	Class II	Active
KMC Biopsy Device, 8 Gauge, Trephine Tip	KMC-015-00	FDA UDI	Class II	Active
KMC Working Channel, 10 Gauge	KMC-008-01	FDA UDI	Class II	Active
KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond Tip	KMC-001-20	FDA UDI	Class II	Active
KMC Bone Cement Delivery System	FG8105	FDA UDI	Class I	Active
One-Shot	FG2711	FDA UDI	Class I	Active
KMC Bone Cement Delivery System	FG8120	FDA UDI	Class I	Active
Bone Biopsy Device	FG2511	FDA UDI	Class II	Active
KMC OneShot Single Balloon Assembly, 8 Gauge, 15mm	KMCA-201-15	FDA UDI	Class II	Active
KMC Drill, 10 Gauge, 200mm	KMC-012-00	FDA UDI	Class II	Active
KMC Working Channel with Cannula, 8 Gauge	KMC-009-00	FDA UDI	Class II	Active
KMC OneShot Double Balloon Assembly, 8 Gauge, 20mm	KMCA-200-20	FDA UDI	Class II	Active
KMC Balloon Catheter, 8 Gauge, 15mm	KMC-003-15	FDA UDI	Class II	Active

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