Rizhao Sanqi Medical & Health Articles Co., Ltd.
Registered establishment in Rizhao, Shandong, China. 18 device types, 1 clearance.
Rizhao Sanqi Medical & Health Articles Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Basin, Emesis, Cap, Surgical and 16 other device types. Its earliest product listing with the FDA dates from 2013.
18device types registered with the FDA
1510(k) clearance
Registration
| Registered name | RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010374972 |
| FEI number | 3010374972 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 日照三奇医疗卫生用品有限公司 |
|---|---|
| Unified social credit code | 91371100168371999W |
| Source | NMPA UDI database |
Location
| City | Rizhao |
|---|---|
| Province | Shandong |
| Address | Heshan Industrial area |
| Postal code | 276800 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Absorber, Saliva, Paper | 2013 | 86 |
| Accessory, Surgical Apparel | Class 1 | Accessory, Surgical Apparel, check pants,Sleeve cover, Medical Face Shield with or without Glass | 2013 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Disposable Sampling Swab | 2023 | 186 |
| Apron, Protective | Class 1 | Dental apron /shawl,bib,apron | 2016 | 46 |
| Bandage, Elastic | Class 1 | Dressing kit for Medical Use | 2016 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | wet tissues, Bandage, Liquid, Skin Protectant | 2013 | 41 |
| Basin, Emesis | Class 1 | Sickness bag with absorbent pad;, Sickness bag;, Super-absorbent pouch; Vomit Bag;, Vomit bag with absorbent pouch, Hygienic bag with super absorbent pads;, Dispenser and 1 more | 2026 | 65 |
| Bedding, Disposable, Medical | Class 1 | Bedding, Disposable, Medical, Medical Bed Sheets, Medical pillow cover, medical drape, underpad | 2013 | 308 |
| Cap, Surgical | Class 1 | Cap, Surgical, Caps,hood,Surgical cap,Surgical cap,DOCTOR CAP,Nurse cap,clip cap,protection hood | 2013 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, Operating-Room, check pants,Sleeve cover | 2013 | 176 |
| Disinfectant, Medical Devices | Class 1 | wet wipes | 2017 | 197 |
| Fiber, Medical, Absorbent | Class 1 | Hygienic bag; Hygienic bag with super absorbent pad;, Absorbent Core Paper; Absorbent Pad; Absorbent Paper;, Commode liner with super absorbent pad; Fiber Medical Absorbent;, Sanitary Absorbent Napkin; Super-absorbent pouch, Biohazard Specimen Bag with super absorbent pad; Commode Liner;, Absorbent sheet; Biohazard Specimen Bag; | 2026 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze/Sponge,Nonresorbable For External Use, Medical Gauzes,Medical Gauzes roll | 2013 | 266 |
| Mask, Surgical | Class 2 | Surgical Face Mask Level 1/2/3 Blue, white, pink, green, yellow, Surgical Face Mask | 2020 | 125 |
| Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) | Class N | 3Q KN95, RIZQ100Sb, 3Q FFP 2 NR, 3Q KN95 9505, RIZ100CVb | 2020 | 4 |
| Non-Surgical Gown | Class 1 | Non-Surgical Isolation Gown, gowns,coverall,medical gown,Isolation Gowns,protection grown/coverall,lab coat,patient cloth | 2013 | 318 |
| Respirator, Surgical | Class 2 | NIOSH Surgical N95 Particulate Respirator SQ100Sc, NIOSH Surgical N95 Particulate Respirator SQ100Gs | 2021 | 118 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Protective Goggles with or without Vent | 2023 | 384 |
Clearances
1 clearance names Rizhao Sanqi Medical & Health Articles Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202903 | 2022-03-24 | FXX | Traditional | This company |
| K093901 | 2010-09-10 | FXX | Traditional | Epard Protective Products, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Factory area | 42000 m² |
| Main products | FFP3 particle filtering half masks, Type IIR medical face masks, Surgical face masks, Chemical protective coveralls, Non-woven fabrics |
| Export markets | US, Japan, EU |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Huge Dental Material Corporation | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | 7 |
| Shandong INT Medical Instruments Co., Ltd. | 4 |
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.