FDA Registration
Active
🇨🇳 China
CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO.,LTD
Reg #: 3012922212
·
FEI: 3012922212
·
Expires 2026
Products
12
Proprietary Names
12
Establishment Types
2
Classifications
12
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Registration Details
- Registration Name
- CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO.,LTD
- Registration Number
- 3012922212
- FEI Number
- 3012922212
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 57 Limao Road, Lijia Town, Wujin District
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Changzhou Shengkang Medical Instrument Co.,LTD
- Operator Number
- 10095334
- Address
- No. 57 Limao Road, Lijia Town, Wujin District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
- Correspondent
- NANPING WANG
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 |
|---|---|---|---|---|---|
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2026-02-27 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2026-02-27 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2026-02-27 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2026-02-27 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2026-02-27 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2026-02-27 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2026-02-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2026-02-27 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2026-02-27 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2026-02-27 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2026-02-27 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2026-02-27 |
Proprietary Names
Dental tray
Disposable dental irrigation needles
Disposable dental cotton rolls
Disposable dental mirror
Disposable dental saliva ejector
Micro applicator
Polishing brush
Disposable dental bib roll, Disposable dental bib (towel tray)
Gauze
Air water syringe tip
Disposable dental probe
Disposable dental tweezers
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device