FDA Registration
Active
🇨🇳 China
CHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO., LTD.
Reg #: 3016994953
·
FEI: 3016994953
·
Expires 2026
Products
16
Proprietary Names
16
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- CHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO., LTD.
- Registration Number
- 3016994953
- FEI Number
- 3016994953
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19# Building 1st and 2nd Floor No.47 Qingyang North Road Tianning District
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Changzhou 3R Medical Device Technology Co., Ltd.
- Operator Number
- 10068123
- Address
- 19# Building 1st and 2nd Floor No.47 Qingyang North Road Tianning District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213017
- Country
- CN
- Correspondent
- runting Tian
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 |
|---|---|---|---|---|---|
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2023-02-21 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2023-02-21 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2020-04-08 |
| 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 | 2020-04-08 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2026-03-10 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-04-08 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2024-12-21 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-04-08 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-08 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2023-02-21 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2023-02-21 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2020-04-08 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-08 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-04-08 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2023-02-21 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2021-11-19 |
Proprietary Names
STAPLE, REMOVABLE (SKIN)
FORCEPS, BIOPSY, NON-ELECTRIC
DRESS, SURGICAL
Face Mask Within the Scope of the Face Mask and Barrier Face Covering Enforcement Policy or Face Mask Umbrella EUA
Stapler
Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Applier, staple, surgical,
COVER, SHOE, OPERATING-ROOM
Non-surgical gown
CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
ACCESSORY, SURGICAL APPAREL
CAP, SURGICAL
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Trocar
Establishment Types
Manufacture Medical Device