FDA Registration
Active
🇨🇳 China
XIANTAO SANDA INDUSTRIAL CO., LTD
Reg #: 3008048818
·
FEI: 3008048818
·
Expires 2026
Products
12
Proprietary Names
26
Establishment Types
3
Classifications
12
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Registration Details
- Registration Name
- XIANTAO SANDA INDUSTRIAL CO., LTD
- Registration Number
- 3008048818
- FEI Number
- 3008048818
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.46, East Of Huangjin Avenue,Xiantao
- City
- Xiantao Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222651
Owner / Operator
- Firm Name
- XianTao Sanda Industrial Co., Ltd
- Operator Number
- 10030643
- Address
- NO.46 GOLDEN AVENUE
- City
- Xiantao
- State
- Hubei
- Postal Code
- 433000
- Country
- CN
- Correspondent
- Leo Hu
US Agent
- Business Name
- PUREVISION AI, INC. (DBA PURE GLOBAL)
- Contact Name
- Bryan Wong
- Address
- 111 Town Square Pl Ste 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 888 7681688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-12-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-07-25 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2010-03-18 |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | NZJ | Class 2 | General Hospital | No | 2020-12-03 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2009-10-27 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2013-01-20 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2009-10-27 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-12-03 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2009-10-27 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2009-10-27 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2009-10-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2009-10-27 |
Proprietary Names
Surgical Face Mask
MEDICAL NURSING PAD
Face mask
KN95
N95
Respirator
Protective Mask
MICROSURGERY SLEEVE
KNIFE SLEEVE
Sleeve
Nursing Pad
ULTI-MED SURGICAL CAP
SURGICAL CAP
BOUFFANT CAP
Medical Face Mask
Disposable Face Mask
Dust Mask
Fluid Impervious Gowns
Isolation gown
Medicom Isolation Gowns
Shoe cover
MEDICOM SHOE COVERS
SCRUB SUITS
COVERALLS
PROTECTOR GOWNS
STAFF COATS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)