FDA Registration
Active
🇨🇳 China
EXCELLENT MEDICAL TECHNOLOGY GROUP CO., LTD.
Reg #: 3018058145
·
FEI: 3018058145
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- EXCELLENT MEDICAL TECHNOLOGY GROUP CO., LTD.
- Registration Number
- 3018058145
- FEI Number
- 3018058145
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road,, Xiangcheng District
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220665
Owner / Operator
- Firm Name
- Excellent Medical Technology Group Co., Ltd.
- Operator Number
- 10082410
- Address
- Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road,, Xiangcheng District
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215131
- Country
- CN
- Correspondent
- Kenney SONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2021-07-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2021-07-24 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-07-24 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-07-24 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2022-02-15 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2022-07-06 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2021-07-24 |
Proprietary Names
Ice bags, Bags for Ice containing
cold pack; pack for ice
Underpad, bedding sheet, super-absorbent underpad, medical absorbent pad,
Non-Surgical Isolation Gown, Isolation gown, liquid Isolation gown
Drape, Surgical drape, operation drape, towel drape
Stockinette, Stockinette tube,
Gowns, surgical; AAMI Lever 3 Protection Gowns for surgeon
Adult Diaper, Diaper, Diaper for incontinence, disposable pants for incontinence
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198