Shanghai Lange Medtech Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 16 device types, 7 products catalogued, 1 clearance.
Shanghai Lange Medtech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Tamp, Forceps and 14 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
16device types registered with the FDA
7products catalogued under its own name
1510(k) clearance
Registration
| Registered name | SHANGHAI LANGE MEDTECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3035858921 |
| FEI number | 3035858921 |
| DUNS | 549889938 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海朗迈医疗器械科技有限公司 |
|---|---|
| Unified social credit code | 91310117599759792R |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 1st floor, Building 22, 1500 Duhui Road, Minhang District |
| Postal code | 201108 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Arthroscope | Class 2 | Kyphoplasty Balloon Dilatation Catheters S01-1610, S01-1615, S01-1620 | 2026 | 21 |
| Bone Marrow Biopsy Tray | Class 1 | Bone Biopsy Devices, 3.5×150, 3.5×200 | 2025 | 1 |
| Dilator, Catheter | Class 1 | Dilators,?2.5×220 ?5×200 ?7×185 ?13×140, Dilators, ?2.5x?5×200, ?5x?7×185, ?7x?9×170, ?9x?11×155, ?11x?13×140, ?13x?15×125, Dilators, ?2.5x?7×200 | 2025 | 7 |
| Dissector, Surgical, General & Plastic Surgery | Class 1 | Muscle Expander,160 | 2025 | 14 |
| Forceps | Class 1 | Kerrison Forceps, 3x180x90°, 2x180x130°, 4x180x130°, 2x180x130°; Kerrison Forcep Handle 75, 75 Black coating | 2025 | 99 |
| Head, Surgical, Hammer | Class 1 | Hammer,220 | 2025 | 2 |
| Hook, Surgical, General & Plastic Surgery | Class 1 | Nerve Probe,?1.5×220 ?1.5×220 ?1.5×240 | 2025 | 19 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Class 1 | Steerable Bone Cement Filler Devices, S13-05, S13-03, Bone Cement Filler Devices, S03-01, S03-02, S03-03, S03-04, Bone Cement Application Kits, S02-10, S02-101, S12-20, S12-201, Gun-shaped Bone Cement Filler Devices,S14-02 | 2025 | 5 |
| Instrument, Cutting, Orthopedic | Class 1 | Punches, 4×175 | 2025 | 11 |
| Instrument, Manual, Surgical, General Use | Class 1 | Drainage Tube, 3.5×203, 5.5×203, 4.5×220 | 2025 | 110 |
| Retractor | Class 1 | Retractor, 12×188 12×188 6×186 12×188 194 194 193 ?15×188 ?15x188x120° ?15x188x120° ?10×60 ?15×60 ?15. | 2025 | 34 |
| Spatula, Surgical, General & Plastic Surgery | Class 1 | Bone Chisel, 5×250, 5x250x35°, 5x250x35° ,5x250x20° ,5x250x38°, 5×310, 8x8x295 | 2025 | 12 |
| Spinal Channeling Instrument, Vertebroplasty | Class 1 | Dilator inner tubes, S08-01, S08-03, Dilator outer tubes, S10-01, S10-02, S10-03, Puncture needles, S05-02, S05-03, S05-04, S05-05, S05-08, S05-09, S05-10, Guide Wires, S09-01, Balloon Inflation Devices, S06-30, Bone drills, S04-30, S04-34 | 2025 | 5 |
| Stripper, Vein, Reusable | Class 1 | Minimally Invasive Spinal Surgery Access Expansion Tube,160 | 2025 | 3 |
| Tamp | Class 1 | Kyphoplasty Balloon Dilatation Catheters S01-1610, S01-1615, S01-1620 | 2026 | 7 |
| Tray, Surgical | Class 1 | Instrument Tray | 2025 | 36 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Kyphoplasty Balloon Dilatation Catheters | HRX | 3 |
| Bone Drills | OCJ | 2 |
| Puncture Needles | OCJ | 1 |
| Balloon Inflation Devices | OCJ | 1 |
| Guide Wires | OCJ | 1 |
| Gun-shaped Bone Cement Filler Devices | OAR | 1 |
| Bone Cement Filler Devices | OAR | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252458 | 2025-11-03 | HRX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Minimally invasive spine instruments, Orthopedic devices, Biomaterials |
| Certifications | High-tech enterprise, Shanghai specialized and refined enterprise |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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