FDA Registration
Active
🇨🇳 China
CHENGDU SANI MEDICAL EQUIPMENT CO.,LTD.
Reg #: 3015060193
·
FEI: 3015060193
·
Expires 2026
Products
12
Proprietary Names
17
Establishment Types
3
Classifications
12
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Registration Details
- Registration Name
- CHENGDU SANI MEDICAL EQUIPMENT CO.,LTD.
- Registration Number
- 3015060193
- FEI Number
- 3015060193
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 408, Tengfei 4th Road, Southwest Airport Economic Development Zone, Shuangliu District
- City
- Chengdu Sichuan
- Country
- CN
Owner / Operator
- Firm Name
- Chengdu Sani Medical Equipment CO.,LTD.
- Operator Number
- 10058743
- Address
- No. 408, Tengfei 4th Road, Southwest Airport Economic Development Zone, Shuangliu District
- City
- Chengdu
- State
- Sichuan
- Postal Code
- 610207
- Country
- CN
- Correspondent
- qiuping Zhang
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 |
|---|---|---|---|---|---|
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2024-02-28 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2021-01-28 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-11 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2024-05-13 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2025-05-11 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-11 |
| 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 | 2020-04-14 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2018-10-24 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2021-01-28 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2018-10-24 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2021-01-28 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2025-05-11 |
Proprietary Names
Electric Torque Driver
Gutta Percha Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M, Gutta Percha Bar
Isolation clothing
Orthodontic Wires
Palatal Expander
Face shield
Face Mask
S3 Rotary Endo Files, KID Rotary Endo Files, S PRO Rotary Endo Files
BS Rotary Endo Files, U File, Super C Root Canal Files, REAMERS Root Canal Files, K Files Root Canal Files,
H Files Root Canal Files, TAPER FILE Rotary Endo Files, G3 Rotary Endo Files, Super Pass Rotary Endo Files,
Absorbent Paper Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M
Blue Diamond Bur
Carbide Bur; Stainless Bur
Obturation System - Easy Fill; Obturation Downpack Device - Easy Pack; Condenser-N35/S70, N40/S80,N50/S100, N60/S120
Composite instruments
Dental Mirror
Micro Mirror
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device