FDA Registration
Active
🇨🇳 China
WENZHOU DONGFANG MEDICAL INSTRUMENTS CO., LTD
Reg #: 3004784770
·
FEI: 3004784770
·
Expires 2026
Products
10
Proprietary Names
22
Establishment Types
4
Classifications
10
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Registration Details
- Registration Name
- WENZHOU DONGFANG MEDICAL INSTRUMENTS CO., LTD
- Registration Number
- 3004784770
- FEI Number
- 3004784770
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #143, Zhongxin Road, Wenzhou Industry Zone
- City
- WENZHOU Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K081951
Owner / Operator
- Firm Name
- WENZHOU KINDCARE IMPORT & EXPORT CO.,LTD
- Operator Number
- 9066722
- Address
- F407,ZHANNAN COMMERCIAL & TRADING BLDG
- City
- WENZHOU
- State
- Zhejiang
- Postal Code
- 325000
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2004-09-16 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2008-07-30 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2012-03-07 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2007-02-08 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-05-03 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-04-04 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2006-09-25 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2015-10-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2008-07-02 |
Proprietary Names
KINDCARE STETHOSCOPE
INJECTION PAD
Tourniquet ,nonpneumatic
B.P. MONITOR WITH STETHOSCOPE
Blood Pressure Monitor
Blood Pressure Cuff
ISOLATION GOWN
PENLIGHT
KINDCARE OTOSCOPE
Medical Respirator
KN95 Mask
Sand Protection Goggles
Goggles
Safety Goggles
Medical Goggles
Nursing Goggles
Protective Glasses
Snow Goggles
REFLEX HAMMER
Bandage Scissors
Face Shield
Disposable Face Mask
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)