FDA Registration
Active
🇨🇳 China
SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.
Reg #: 3009431661
·
FEI: 3009431661
·
Expires 2026
Products
10
Proprietary Names
9
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.
- Registration Number
- 3009431661
- FEI Number
- 3009431661
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 103, Building 3, No. 2, Weiqun Road, 4th Community, Henggang Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222548
Owner / Operator
- Firm Name
- Shenzhen Perfect Medical Instruments Co., Ltd.
- Operator Number
- 10041190
- Address
- Room 103, Building 3, No. 2, Weiqun Road, 4th Community, Henggang Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518115
- Country
- CN
- Correspondent
- Abby Woo
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 |
|---|---|---|---|---|---|
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2012-06-28 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2023-10-19 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2023-10-19 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2023-05-06 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2023-05-06 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2024-06-25 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2012-06-28 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2012-06-28 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2023-04-13 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2023-10-19 |
Proprietary Names
FILE, PULP CANAL, ENDODONTIC; profa file
Gutta Percha Points, Injectable Root Canal Sealer
Absorbent Paper Points
Endo Motor
Irrigation Needle
BUR, DENTAL; profa dental bur
WIRE, ORTHODONTIC; profa wires
Gutta Percha Cutting Pen
Ultrasonic irrigation activator, Irrigation activator, Wave Tip, Working Tip
Establishment Types
Manufacture Medical Device