Shandong Kangli Medical Equipment Technology Co., Ltd.
Registered establishment in Zaozhuang, Shandong, China. 23 device types, 1 clearance.
Shandong Kangli Medical Equipment Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Forceps, Pad, Kelly and 21 other device types. Its earliest product listing with the FDA dates from 2018.
23device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014666579 |
| FEI number | 3014666579 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 山东康力医疗器械科技有限公司 |
|---|---|
| Unified social credit code | 91370400727541190A |
| Source | NMPA UDI database |
Location
| City | Zaozhuang |
|---|---|
| Province | Shandong |
| Address | Huiquan East Road, Shizhong District, Zaozhuang City, Shangdong Province, China |
| Postal code | 277117 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swab | 2018 | 186 |
| Bag, Stomal | Class 1 | Colostomy Bag | 2018 | 7 |
| Bandage, Elastic | Class 1 | Sterile Gauze Bandages | 2018 | 280 |
| Bedding, Disposable, Medical | Class 1 | Sterile Draw Sheets | 2018 | 308 |
| Cap, Surgical | Class 1 | Sterile Surgical Caps | 2018 | 178 |
| Closure, Wound, Adhesive | Class 1 | Transclucent PU Film Dressing | 2018 | 22 |
| Cover, Mattress (Medical Purposes) | Class 1 | Bed Cover | 2018 | 89 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe cover | 2020 | 176 |
| Drape, Surgical, Exempt | Class 2 | General Operation Drape, Head Drape, Coronary Angiography Drape, Breast Drape, Cesarean section Drape, Laparotomy Drape and 1 more | 2018 | 107 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Keto-silicone Dressing, Medical Hydrocolloid Dressing, PU Foam Dressing | 2018 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Hydrofiber, Medical Calcium Alginate Dressing | 2018 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Sterile Self-adhesive Wound Dressings, Swelling Chitosan, Transparent dressing | 2018 | 183 |
| Fiber, Medical, Absorbent | Class 1 | Cotton Ball | 2018 | 172 |
| Forceps | Class 1 | Plastic Tweezers | 2018 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Pad, Gauze Piece | 2018 | 266 |
| Gown, Surgical | Class 2 | Disposable medical surgical gown | 2020 | 68 |
| Instrument, Surgical, Disposable | Class 1 | Wrapping Cloth | 2018 | 45 |
| Non-Surgical Gown | Class 1 | Disposable Medical Protective Clothing, Isolation gown | 2020 | 318 |
| Pad, Kelly | Class 2 | Disposable Transfer Sheets | 2018 | 5 |
| Pouch, Colostomy | Class 1 | Colostomy bags | 2020 | 25 |
| Protector, Ostomy | Class 1 | Adhesive Strips, Adhesive Mouldable Ring, Barrier Cream | 2018 | 33 |
| Sheet, Burn | Class 1 | Bed Sheets | 2018 | 20 |
| Tape And Bandage, Adhesive | Class 1 | Medical Tapes | 2018 | 353 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192560 | 2020-05-22 | FYA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1989 |
|---|---|
| Main products | surgical gowns, disposable gloves, surgical drapes, face masks, medical devices |
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.
The manufacturer named here can complete this record.