FDA Registration
Active
🇨🇳 China
Intraoral Scanner SCAN11
Reg #: 3008252267
·
FEI: 3008252267
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Ningbo Runyes Medical Instrument Co., Ltd.
- Registration Number
- 3008252267
- FEI Number
- 3008252267
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 456 Tonghui Road, Jiangbei Investment & Pioneering Par C
- City
- Ningbo Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Ningbo Runyes Medical Instrument Co., Ltd.
- Operator Number
- 10052869
- Address
- No. 456 Tonghui road, Jiangbei Investment & Pioneering Park C
- City
- Ningbo
- State
- CN-NOTA
- Postal Code
- 315033
- Country
- CN
US Agent
- Business Name
- 510kfda, Inc
- Contact Name
- Claude Berthoin
- Address
- 156 E Granada Blvd
- City
- Ormond Beach
- State
- FL
- ZIP
- 32176
- Country
- US
- [email protected]
- Phone
- 386 8710908
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2018-08-28 |
Proprietary Names
Intraoral Scanner SCAN11
Runyes 3DS Intraoral Scanner IOS-11
QuickScanIOS
Intraoral Scanner 3DS Mega
Intraoral Scanner R2i3
Intraoral Scanner 3DS Ultra
Intraoral Scanner ORAL-O3
Intraoral Scanner SCAN-V5
iGrapher
Intraoral Scanner SCAN-V6
Intraoral Scanner SCAN33
Intraoral Scanner SCAN-O5
Intraoral Scanner SCAN-i5
Intraoral Scanner SCAN-i6
Intraoral Scanner SCAN-O6
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device