FDA Registration
Active
🇨🇳 China
Changzhou IVORIE Shengmei Packaging Technology Co.Ltd
Reg #: 3014314529
·
FEI: 3014314529
·
Expires 2026
Products
12
Proprietary Names
24
Establishment Types
2
Classifications
12
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Registration Details
- Registration Name
- Changzhou IVORIE Shengmei Packaging Technology Co.Ltd
- Registration Number
- 3014314529
- FEI Number
- 3014314529
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.3, Xia Ming Road, Hengshanqiao Town, Economic Development District
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Changzhou IVORIE Shengmei Packaging Technology Co.Ltd
- Operator Number
- 10056830
- Address
- No.3, Xia Ming Road, Hengshanqiao Town, Economic Development District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213117
- Country
- CN
- Correspondent
- Zhiyue Ding
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 |
|---|---|---|---|---|---|
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2018-01-19 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2018-01-19 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2018-01-22 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2018-01-19 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2018-01-19 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2018-01-22 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2021-12-02 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2018-01-22 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2018-01-22 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2018-01-22 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2018-01-22 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2018-01-19 |
Proprietary Names
Teeth Wipes,Brush Ups,Finger Brush,Oral Brush Ups
Foam Strip Mouth Tray/Gel Prefilled Mouth Tray/ Bruxism mouth guard
Thermoplastic Mouth Tray/Mouth Piece/Sports mouth guard/Teeth Whitening Mouth Tray
Denture Cleansing Tablet
Vitamin E Swab
Anti Snore Belt/Chin Strap Belt/Snoring Vent/stop snoring tongue
Stop Snoring Chin Strap/Anti Snore Jaw Supporter/Stop Snoring Solution
Teeth whitening Led Light(MD666); Teeth Whitening Mouth Tray Led Light;
Teeth Whitening Mouth Tray Light; Portable Teeth Whitening Light;
Teeth Whitening Light 8led/16led; Teeth Whitening Accelerator; Plusma Light; Teeth Whitening Light;
Smart Teeth Whitening Light; Teeth Whitening Lamp)
HEAT SOURCE FOR BLEACHING TEETH (Teeth Whitening Mini Light; Mini Light 1led/5led;
Teeth whitening Led Light 8led/16ledSmart Teeth Whitening Device;
Water flosser/Oral Irrigator
Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel
Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips
Teeth Whitening Pen/Empty Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml
Coconut oil pulling; Coconut oil sachet, Oral care kit, Toothpaste
PROFESSIONAL WHITENING GEL; Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit
Double Elastic Gel Strips/Dry Strips/Dissolving Strip; teeth whitening powder; charcoal teeth whitening powder
Teeth Whitening System; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel;
Anti Snore Mouth Piece/Snoring Stopper/Anti Snore Mouth Tray/Stop Snoring Solution/Anti Snore Kit/Stop Snoring Device
Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush
Cheek Retractor/Mouth Opener/Lip Retractor
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device