FDA Registration
Active
🇨🇳 China
XINHUA HEALTHCARE INDUSTRY CO.,LIMITED
Reg #: 3013875765
·
FEI: 3013875765
·
Expires 2026
Products
30
Proprietary Names
99
Establishment Types
2
Classifications
30
Registration Details
- Registration Name
- XINHUA HEALTHCARE INDUSTRY CO.,LIMITED
- Registration Number
- 3013875765
- FEI Number
- 3013875765
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.2999 Zunxian Road, Zibo New & Hi-tech Zone
- City
- Zibo Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Xinhua Healthcare Industry Co.,Limited
- Operator Number
- 10055614
- Address
- No.2999 Zunxian Road, Zibo New & Hi-tech Zone
- City
- Zibo
- State
- Shandong
- Postal Code
- 255086
- Country
- CN
- Correspondent
- Hong Kou
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 |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2017-08-23 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2017-08-23 |
| Probe | HXB | Class 1 | Orthopedic | No | 2017-08-23 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-08-23 |
| File | HTP | Class 1 | Orthopedic | No | 2017-08-23 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2017-08-23 |
| Bender | HXW | Class 1 | Orthopedic | No | 2017-08-23 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2017-08-23 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2017-08-23 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2017-08-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2017-08-23 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2017-08-23 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2017-08-23 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2017-08-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-08-23 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2017-08-23 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2017-08-23 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2017-08-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-08-23 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2017-08-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2017-08-23 |
Proprietary Names
Depth Gauge
Bone Measurer
Gauge
Liner Extractor
Coxae Chisel
Chisel
Bone-chisel
Plate Cutter
Rod Cutter
Wire Plier Cutter
Uterine Curette
Bone Needle
Bone marrow agent
Screwdriver
Orthopedic screwdriver
Acetabular bone rasp
Medullary space rasp
Bone file
Bone lever
Nerve Dissector
Periosteal Elevator
Micro Dissector
Plate Bender
Rod Bender
Bar Bender
Bone curet
Awl
Screw Tap
Tip
Screw Clamp
Reduction forceps of orthopaedics
Holder
Bone Clamp
Plate Holder
Hook Holder
Three-jaw reduction forceps
Reduction forceps of pelvic
Rod Holder Forceps
Compressing Forceps
Rod Clamp
Break Off Iron
Drill Bit
Counter Drill
Hook Trail
Cavum Medullary Enlarging Drill
Drill guide
Remover Of Broken Bone Screws
Screw Holding Forceps
Easyout
Extractor
Trephine
Screw Driver
Flexible Reamer Shaft
Bone Reamer
Bone Locating Plate
Thighbone Marrow Cavity Alignment Hand Shank Cover
Quick-change Handle
Knee unbending interval gasket
Goniometer
Cutter and Bender
Cutter
Bone Rongeur
Screw Holder Forceps
Holding Forceps
Adjustable fixed support
Kerrison Punch
Laminectomy Rongeur
wire saw gride
Bone Drill gunsight
Wire Guide
Ti-Cage Cutting Scissors
Pin Cutting Scissors
Wire Cutting Scissors
Sliding Hammer
Bone Mallet
Impactor
Mold Trial
Coxae Retractor
Distractor
Coxae Drag Hook
Skin Drag Hook
Joint Retractor
Bone Drag Hook
Tissue Drag Hook
Variable Retractor
Nerve Root Retravtor
Bone Spreader
Cervical Retractor
Centrum Spreader
Bone Retractor
Rod pusher
Bone Register pin
Protecting Sleeve
Bone Graft Funnel
Fixation Probe
Pin
Crochet needle
Graft Impacter
Template
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device