FDA Registration
Active
🇨🇳 China
HANGZHOU STELLARMED MEDICAL TECHNOLOGY CO.,LTD
Reg #: 3017911818
·
FEI: 3017911818
·
Expires 2026
Products
15
Proprietary Names
15
Establishment Types
4
Classifications
15
Registration Details
- Registration Name
- HANGZHOU STELLARMED MEDICAL TECHNOLOGY CO.,LTD
- Registration Number
- 3017911818
- FEI Number
- 3017911818
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 212, Floor 2, Building 2, No.9 Taiji Road, Yunhe Street, Yuhang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220210
Owner / Operator
- Firm Name
- Hangzhou Stellarmed Medical technology Co.,Ltd
- Operator Number
- 10079659
- Address
- Room 212, Floor 2, Building 2, No.9 Taiji Road, Yunhe Street, Yuhang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311000
- Country
- CN
- Correspondent
- Kerry Hu
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 |
|---|---|---|---|---|---|
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2020-12-17 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-06-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-02-21 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-12-17 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2021-09-18 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2022-09-27 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2020-12-17 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2022-02-21 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2021-09-18 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2020-12-17 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2021-09-18 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2024-04-10 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-09-18 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2021-09-18 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2020-12-17 |
Proprietary Names
Device Organizer
Poly trap
Tray,Surgical, Instrument-Water Basin,Tray
Coloshield Procedure Drape, Non-Sterile, Single Use
Bedding, Disposable, Medical-Transport Pad
Non-Surgical isolation gown
ESD Specimen Tray,with pins
Cleaner,Ultrasonic,Medical Instrument-Endoscopy Kit
Bite Block
Single use biopsy forceps
Lubricant, Patient-Sterile Lubricating Jelly
Disposable Endoscopy Adapter Set
Gauze, Sponge, Nonresorbale For Extermal-Gauze
Tubing, Noninvasive-Suction Tubing
Single use cleaning brush
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device