FDA Registration
Active
🇨🇳 China
RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD
Reg #: 3010374972
·
FEI: 3010374972
·
Expires 2026
Products
18
Proprietary Names
41
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD
- Registration Number
- 3010374972
- FEI Number
- 3010374972
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Heshan Industrial area
- City
- Rizhao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K093901
Owner / Operator
- Firm Name
- RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD
- Operator Number
- 10044543
- Address
- Heshan Industrial area, Donggang District
- City
- Rizhao
- State
- Shandong
- Postal Code
- 276800
- Country
- CN
- Correspondent
- Julia Yu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-05-28 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2013-06-25 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2016-12-12 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2013-06-25 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2017-12-23 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2026-06-17 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-01-30 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2023-03-15 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2013-06-25 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2021-06-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2013-06-25 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2013-06-25 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2026-06-17 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2013-06-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2013-06-25 |
| Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) | QKU | Class N | Unknown | No | 2020-04-22 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2016-12-12 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2013-06-25 |
Proprietary Names
SURGICAL FACE MASK
Bandage, Liquid, Skin Protectant
wet tissues
Dental apron /shawl,bib,apron
Cap, Surgical
Caps,hood,Surgical cap,Surgical cap,DOCTOR CAP,Nurse cap,clip cap,protection hood
wet wipes
Sickness bag with absorbent pad;
Dispenser
Vomit bag with absorbent pouch
Super-absorbent pouch; Vomit Bag;
Emesis bag; Emesis bag with absorbent pouch;
Hygienic bag with super absorbent pads;
Sickness bag;
Disposable Sampling Swab
Protective Goggles with or without Vent
Absorber, Saliva, Paper
NIOSH Surgical N95 Particulate Respirator SQ100Gs
NIOSH Surgical N95 Particulate Respirator SQ100Sc
Surgical Face Mask Level 1/2/3 Blue, white, pink, green, yellow
Non-Surgical Isolation Gown
gowns,coverall,medical gown,Isolation Gowns,protection grown/coverall,lab coat,patient cloth
Cover, Shoe, Operating-Room
check pants,Sleeve cover
Absorbent sheet; Biohazard Specimen Bag;
Sanitary Absorbent Napkin; Super-absorbent pouch
Biohazard Specimen Bag with super absorbent pad; Commode Liner;
Hygienic bag; Hygienic bag with super absorbent pad;
Commode liner with super absorbent pad; Fiber Medical Absorbent;
Absorbent Core Paper; Absorbent Pad; Absorbent Paper;
Gauze/Sponge,Nonresorbable For External Use
Medical Gauzes,Medical Gauzes roll
Accessory, Surgical Apparel, check pants,Sleeve cover, Medical Face Shield with or without Glass
RIZ100CVb
3Q KN95
3Q KN95 9505
RIZQ100Sb
3Q FFP 2 NR
Dressing kit for Medical Use
Bedding, Disposable, Medical
Medical Bed Sheets, Medical pillow cover, medical drape, underpad
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device