FDA Registration
Active
🇨🇳 China
SHENZHEN JPY ION-TECH. CO., LTD.
Reg #: 8043396
·
FEI: 3005461046
·
Expires 2026
Products
20
Proprietary Names
43
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- SHENZHEN JPY ION-TECH. CO., LTD.
- Registration Number
- 8043396
- FEI Number
- 3005461046
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Floor 1, Building 1, Jinpengyuan Industrial Park, No. 951, Baihuayuan Road, Baihua Community, Guangming Street
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- SHENZHEN JPY ION-TECH. CO., LTD.
- Operator Number
- 10095160
- Address
- Floor 1, Building 1, Jinpengyuan Industrial Park, No. 951, Baihuayuan Road, Baihua Community, Guangming Street
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518107
- Country
- CN
- Correspondent
- Liang He
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2026-05-21 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-05-22 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2026-05-21 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2026-05-21 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2026-05-21 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2026-05-21 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2026-05-21 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2026-05-08 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2026-05-21 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2026-05-09 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2026-05-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-05-21 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2026-05-22 |
| Oral Wound Dressing | OLR | Class U | Unknown | No | 2026-05-21 |
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 2026-05-21 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2026-05-22 |
| Eyelid Thermal Pulsation System | ORZ | Class 2 | Ophthalmic | No | 2026-05-21 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2026-01-30 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2026-05-21 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2026-05-22 |
Proprietary Names
Nasal Dressing
LUOFUCON PHMB Alginate Dressing (Prescription)
LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC)
Pasteur Pipette
CALCIUM ALGINATE Ag
Biatain Fiber Ag
LUOFUCON Collagen Wound Dressing
Standard Trocar
LUOFUCON Silver Collagen Dressing
VARIOUS INJECTION & SUTURING NEEDLE
CUTTERS,DISSECTORS,BLOOD LANCETS
Exu-Dry Burn Sheets, Conformant
SUNTOUCH Topical Hemostatic Dressing
foam dressing
LUOFUCON HyperSorb Hydrofiber Wound Pad
LUOFUCON Alginate Dressing
LOOP/SQUARE ELECTRODE
Disposable Bi-polar Cable
Suction Coagulator
LLETZ LOOP Electrode
AMD antimicrobial foam dressing
SUNTOUCH Eye Spear
SUNTOUCH Dental Dressing
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
SUNTOUCH Ear Tampon
DISPOSABLE SKIN STAPLER
Eyelid thermal pulsation system
Drynet
Biatain Fiber
Electrosurgical, cutting & coagulation & accessories
Electrosurgery pencil
LUOFUCON Sliver PU Antibacterial Foam Dressing
Antibacterial Alginate Wound Dressing (OTC)
LUOFUCON Extra Silver Alginate Dressing (Prescription)
Inoculation Loops; Inoculation Need
LUOFUCON Silver Alginate Dressing (Prescription)
LUOFUCON Antibacterial Alginate Dressing (OTC)
Square dish
Culture Dish 90mm
Oocyte Collection Tube 14 mL
Sample Tube 5ml
Medical Sponge Tips
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)