FDA Registration
Active
🇨🇳 China
GUANGZHOU OO MEDICAL SCIENTIFIC LIMITED
Reg #: 3013561919
·
FEI: 3013561919
·
Expires 2026
Products
17
Proprietary Names
15
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- GUANGZHOU OO MEDICAL SCIENTIFIC LIMITED
- Registration Number
- 3013561919
- FEI Number
- 3013561919
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Add 1: Room 826, Building G1, No. 31 Kefeng Road, Huangpu District;, Add 2: Rm 203,Bldg 13,No. 8,Lianyun Rd
- City
- Guangzhou Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- GUANGZHOU OO MEDICAL SCIENTIFIC LIMITED
- Operator Number
- 10054513
- Address
- Add 1: Room 826, Building G1, No. 31 Kefeng Road, Huangpu District;, Add 2: Rm203,Bldg 13,No. 8,Lianyun Rd
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510670
- Country
- CN
- Correspondent
- Cathy Guo
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 |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-04-23 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2023-11-21 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2024-12-08 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2017-03-28 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2021-07-04 |
| 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 | 2020-05-07 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-12-08 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2025-12-30 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2023-11-21 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2017-03-28 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2020-11-27 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2025-12-30 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2024-04-23 |
| Floss, Dental | JES | Class 1 | Dental | No | 2025-12-30 |
| File, Periodontic | EMR | Class 1 | Dental | No | 2017-03-28 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-04-23 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2023-11-21 |
Proprietary Names
OO Dental, Massage Pillow, Fascia Gun, Massage Ggun, Eye Massager
OO Dental, Orthodontic ligature ties
OO Dental, Spring, Orthodontic
OO Dental, OBRACE, O-EYES, Ceramic brackets
OO Dental
OO Dental, Disposable face mask; KN95 mask
OO Dental, Retainer, Screw Expansion
INDIRECT BONDING TRAY, OO Dental, OO MEDICAL, Orthodontic Indirect Bonding Tray, OBRACE GUIDE
OO Dental, Orthodontic seperators
OO Dental, O-Tube
FORCEPS, DRESSING, DENTAL, OO Dental, OO MEDICAL, Orthodontic Forceps
OO Dental, Orthodontic Tooth Brush, Electric Toothbrush
FLOSS, DENTAL, OO Dental, OO MEDICAL, Toothpaste
OO Dental, Water Flosser
OO Dental, Orthodontic molar band
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device