FDA Registration
Active
🇨🇳 China
BGSS COMPANY ASIA LIMITED
Reg #: 3009219448
·
FEI: 3009219448
·
Expires 2026
Products
25
Proprietary Names
6
Establishment Types
5
Classifications
25
Registration Details
- Registration Name
- BGSS COMPANY ASIA LIMITED
- Registration Number
- 3009219448
- FEI Number
- 3009219448
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 2501, Lindun Building, No.100, North Hengfeng Road
- City
- Zhabei Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K143637
Owner / Operator
- Firm Name
- BGSS COMPANY ASIA LIMITED
- Operator Number
- 10038365
- Address
- Rm 2501, Lindun Bldg, No. 100 N. Hengfeng Rd,
- City
- Zhabei
- State
- Shanghai
- Postal Code
- 200070
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2011-10-09 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2011-10-09 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2011-10-09 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2015-06-16 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2011-10-09 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2011-10-09 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2011-10-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2011-10-09 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2018-11-05 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2011-10-09 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2011-10-09 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2012-03-19 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2011-10-09 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2018-08-22 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2018-11-05 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2011-10-09 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2019-06-11 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2011-10-09 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2011-10-09 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2011-10-09 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2011-10-09 |
| Barrier, Control Panel, X-Ray, Movable | IWX | Class 1 | Radiology | No | 2023-11-06 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2011-10-09 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2018-05-22 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-05-22 |
Proprietary Names
EARLOOP MASK
TRAY COVER
MEDICAL IMAGE STORAGE DEVICE
BARRIER SLEEVES
M3040-BL
Dental Medical 5oz Cups
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor