LEM
LEM - Disposable haemorrhoid banding ligator for use with forceps - complete with rings loader.
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (2), Beijing (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Tongchuang Medical Instrument Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Sapi MED SPA |
|---|---|
| FDA product code | FHN |
| Device type | Ligator, Hemorrhoidal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| 510(k) | K070881 |
| Record published | 2023-07-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Suction LEM with bands | In distribution | |
| Traction LEM with rind loader | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 20 |
| Hemorrhoids Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 16 |
| Millennium | Avalign Technologies, Inc. | 15 |
| Hayden Medical | Hayden Medical Inc | 12 |
| Ligation Device | LEO Medical Co., Ltd. | 12 |
| BR Surgical, LLC | BR Surgical LLC | 11 |
| ESI | FTT Medical, Inc. | 11 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Surtex | Surtex Instruments Ltd | 8 |
| Aesculap | Aesculap AG | 8 |
| Avalign | Avalign Technologies, Inc. | 8 |
Showing 12 of 64. All products under Ligator, Hemorrhoidal
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.