FDA Registration
Active
🇨🇳 China
HANGZHOU WISE MEDICAL DEVICE CO.,LTD
Reg #: 3043149181
·
FEI: 3043149181
·
Expires 2026
Products
25
Proprietary Names
25
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- HANGZHOU WISE MEDICAL DEVICE CO.,LTD
- Registration Number
- 3043149181
- FEI Number
- 3043149181
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 508, #4 Building, No.672, Xintang Road, Shangcheng District
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Hangzhou Wise Medical Device Co.,Ltd
- Operator Number
- 10094837
- Address
- Room 508, #4 Building, No.672, Xintang Road, Shangcheng District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310000
- Country
- CN
- Correspondent
- SHOUYING LYU
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 |
|---|---|---|---|---|---|
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2025-12-28 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-12-28 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2025-12-28 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2025-12-28 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2025-12-28 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2025-12-28 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-12-28 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2025-12-28 |
| Adhesive, Denture, Acacia And Karaya With Sodium Borate | KOM | Class 1 | Dental | No | 2025-12-28 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2025-12-28 |
| Facebow | KCR | Class 1 | Dental | No | 2025-12-28 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2025-12-28 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2025-12-28 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2025-12-28 |
| Instrument, Contouring, Matrix, Operative | EKF | Class 1 | Dental | No | 2025-12-28 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2025-12-28 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2025-12-28 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2025-12-28 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2025-12-28 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2025-12-28 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2025-12-28 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2025-12-28 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2025-12-28 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2025-12-28 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2025-12-28 |
Proprietary Names
Polishing Strip
Micro screw drive handles, Orthodontic Tools, Self-ligation Tools
Positioner Tooth Preformed
Orthodontic Bracket, Lingual Button
Orthodontic Plier
File, Pulp canal
Accessories, lmplant, Dental, Endosseous, Dental Implant Torque Wrench
Dental crown
Adhesive, Denture (All types)
Orthodontic Tube
Facebow
Orthodotnic Elastics, Orthodontic Hooks, Aligner Chewies, Retainer Retrievers, Invisible Braces Box (ALIGNER BOX)
Patient personal hygiene kit
Orthodontic Wire
Matrices Refill Sectional contoured metal
Bur, Dental
Dental Operating Light (lamp)
Retainer, Screw Expansion Orthodontic
Wax, Dental
Orthodontic Band
Spring, Orthodontic
Maintainer, Space Preformed, Orthodontic
Retractor Orthodontic (All Type retractors)
Disposable anti-particle mask, Face Mask dental
Mirrors Mouth Orthodontic (all types of Orthodontic Mirror Glass and Stainless steel)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)