FDA Registration
Active
🇨🇳 China
SHANGHAI LANGE MEDTECH CO., LTD.
Reg #: 3035858921
·
FEI: 3035858921
·
Expires 2026
Products
16
Proprietary Names
25
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- SHANGHAI LANGE MEDTECH CO., LTD.
- Registration Number
- 3035858921
- FEI Number
- 3035858921
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1st floor, Building 22, 1500 Duhui Road, Minhang District
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K252458
Owner / Operator
- Firm Name
- Shanghai Lange Medtech Co., Ltd.
- Operator Number
- 10092484
- Address
- 1st floor, Building 22, 1500 Duhui Road, Minhang District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201108
- Country
- CN
- Correspondent
- Xin Zhou
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St. Wu
- Address
- 1500 N Grant St Ste R
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2025-01-14 |
| Head, Surgical, Hammer | GFB | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Bone Marrow Biopsy Tray | PXO | Class 1 | General, Plastic Surgery | No | 2025-01-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-05-07 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2026-05-07 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2025-01-14 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2025-09-30 |
Proprietary Names
Bone Chisel, 5x250, 5x250x35°, 5x250x35° ,5x250x20° ,5x250x38°, 5x310, 8x8x295
Retractor, 12x188 12x188 6x186 12x188 194 194 193 ?15x188 ?15x188x120° ?15x188x120° ?10x60 ?15x60 ?15.
Nerve Probe,?1.5x220 ?1.5x220 ?1.5x240
Dilator inner tubes, S08-01, S08-03
Puncture needles, S05-02, S05-03, S05-04, S05-05, S05-08, S05-09, S05-10
Balloon Inflation Devices, S06-30
Guide Wires, S09-01
Dilator outer tubes, S10-01, S10-02, S10-03
Bone drills, S04-30, S04-34
Hammer,220
Punches, 4x175
Bone Biopsy Devices, 3.5x150, 3.5x200
Drainage Tube, 3.5x203, 5.5x203, 4.5x220
Kyphoplasty Balloon Dilatation Catheters S01-1610, S01-1615, S01-1620
Muscle Expander,160
Dilators, ?2.5x?7x200
Dilators, ?2.5x?5x200, ?5x?7x185, ?7x?9x170, ?9x?11x155, ?11x?13x140, ?13x?15x125
Dilators,?2.5x220 ?5x200 ?7x185 ?13x140
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
Steerable Bone Cement Filler Devices, S13-05, S13-03
Instrument Tray
Kerrison Forceps, 3x180x90°, 2x180x130°, 4x180x130°, 2x180x130°; Kerrison Forcep Handle 75, 75 Black coating
Minimally Invasive Spinal Surgery Access Expansion Tube,160
Establishment Types
Manufacture Medical Device