FDA Registration
Active
🇨🇳 China
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
Reg #: 3021349683
·
FEI: 3021349683
·
Expires 2026
Products
13
Proprietary Names
11
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
- Registration Number
- 3021349683
- FEI Number
- 3021349683
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- West Side of 4th Floor, Building E2 West Taihu Medical Industry, Incubator Park No. 9 Changyang Road Wujin District
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232244
Owner / Operator
- Firm Name
- Changzhou Endoclean Medical Device Co., Ltd.
- Operator Number
- 10083616
- Address
- West Side of 4th Floor, Building E2 West Taihu Medical Industry, Incubator Park No. 9 Changyang Road Wujin District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
- Correspondent
- Wang Qi
US Agent
- Business Name
- ZYPPEL LLC
- Contact Name
- Qihui Zhang
- Address
- 1337 Mass Ave Pmb 158
- City
- Arlington
- State
- MA
- ZIP
- 02476
- Country
- US
- [email protected]
- Phone
- 617 2991655
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2023-05-08 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2021-12-06 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2023-04-12 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2021-12-06 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2023-12-07 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2022-10-12 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-05-08 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2021-12-06 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2023-04-13 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2023-04-13 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-04-13 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2022-10-12 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2022-10-12 |
Proprietary Names
Endoscopy Kit
Cleaning Sponge
Disposable Endoscope Valves System
Endoscope channel accessory
Endoscope Channel Accessory
Adaptor, bulbs, miscellaneous, for endoscope
Distal Tip Protector
Lubricating Jelly
Bowl
Transport pad
Endoscope And Accessories
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device