FDA Registration
Active
🇨🇳 China
JIANGSU WLD MEDICAL CO., LTD.
Reg #: 3015140199
·
FEI: 3015140199
·
Expires 2026
Products
50
Proprietary Names
30
Establishment Types
3
Classifications
50
Registration Details
- Registration Name
- JIANGSU WLD MEDICAL CO., LTD.
- Registration Number
- 3015140199
- FEI Number
- 3015140199
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.138, XISHAN SOUTH ROAD, CHENJI TOWN
- City
- YIZHENG Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191642
Owner / Operator
- Firm Name
- JIANGSU WLD MEDICAL CO., LTD.
- Operator Number
- 10059126
- Address
- NO.138 XISHAN SOUTH ROAD, CHENJI TOWN
- City
- YIZHENG
- State
- Jiangsu
- Postal Code
- 211408
- Country
- CN
- Correspondent
- Lily Yang
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 |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2020-01-15 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2026-04-21 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2018-12-03 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2021-05-16 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2026-04-21 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2018-12-05 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2021-05-16 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2019-06-25 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2018-12-05 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2023-08-24 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2018-12-07 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2018-12-07 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2021-05-16 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2024-05-13 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2021-05-16 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2018-12-07 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-11-22 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2018-12-07 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2018-12-03 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2018-12-05 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2018-12-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2018-12-07 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-12-05 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2018-12-03 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2018-12-03 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2021-05-16 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2018-12-05 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2019-06-25 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2019-06-25 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2018-12-07 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2018-12-07 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2024-05-12 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2018-12-05 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2018-12-03 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2018-12-07 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 2021-05-16 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-12-05 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2018-12-07 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-12-03 |
Proprietary Names
Non-surgical isolation gown
Disposable Syringe
Sterile alcohol prep pads
Ostomy Baseplate
Disposable non-woven face mask; Non-woven cap; Nurse BOUFFANT cap; Patient's gowns; Pillow case;
Cotton Filled Gauze; Gauze Bandage; Gauze Roll; Gauze Sponge; Non Woven Swab
Hydrocolloid Adhesive Bandage, Acne Patch
Face Mask
COTTON SWAB, COTTON BALL & COTTON ROLL
IV Cannula
Ostomy Paste, Ostomy Powder, Skin Protective Film
Patient ID Bracelet
Urine Bag
Bedding, disposable, medical - emergency rescue blanket
Disposable Underpad
Examination Table Paper Roll
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
Micropore Nonwoven Tape
Non-woven Cohesive Bandage with Latex
Shoe Cover
Hydrocolloid Dressing
Sharp Container
Pipettes Plastic Droppers
PBT Bandage
Vaginal Speculum
Sterile Dressing
Examination gown
One Piece Ostomy Bag, Two Piece Ostomy Bag
Scrub brush
Disposable syringes with re-use prevention feature with or without needle
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device