FDA Registration
Active
🇨🇳 China
Microscope Drape (WJ250*120J, WJ230*123T, WJ203*110J, WJ215*120J, WJ267*104T, WJ120X100, WJ150X14, WJ150X14A)
Reg #: 3004133236
·
FEI: 3004133236
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- JIANGXI 3L MEDICAL PRODUCTS GROUP CO., LTD
- Registration Number
- 3004133236
- FEI Number
- 3004133236
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.599, Huoju Street, High-tech Development Zone
- City
- Nanchang Jiangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K043015
Owner / Operator
- Firm Name
- JIANGXI 3L MEDICAL PRODUCTS GROUP CO., LTD
- Operator Number
- 9058101
- Address
- No.599, Huoju Street, High-tech Development Zone
- City
- Nanchang
- State
- Jiangxi
- Postal Code
- 330029
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical | KKX | Class 2 | General, Plastic Surgery | No | 2004-01-09 |
Proprietary Names
Microscope Drape (WJ250*120J, WJ230*123T, WJ203*110J, WJ215*120J, WJ267*104T, WJ120X100, WJ150X14, WJ150X14A)
VERTICAL ISOLATION DRAPE (FJ302027)
LAPAROSCOPY DRAPE (FJ301004)
PU Incise Drape (SP4045T, SP5696T, SP5260T)
Cesarean Section drape Sheet (254x291cm, 254x307cm)
PU Incise Drape (SP1410T, SP3825T, SP3841T, SP4860T, SP7090T, SP2815T, SP2830T, SP2845T, SP5545T, SP6085T)
C arm drape cover (195cmx111cm)
HEAD/NECK SET(FJ304005)
55gr laminted film drape-layer with fluid collection pouch (FJ303007, FJ120X100S)
CRANIOTOMY DRAPE (FJ301059)
LOWER VASCULAR DRAPE (FJ301060)
KNEE ARTHROSCOPY DRAPE (FJ301003)
Microscope Drape (WJ180X20A, WJ200X14A)
THORACIC DRAPE (FJ301058)
Ophthalmic Drape Sheet (FJ301006, FJ301054, FJ120X100)
3L SURGICAL DRAPE
40g SMS FABRIC (FJ100*70)
EXTREMITY DRAPE (FJ301055)
HAND/FOOT DRAPE (FJ301056 FJ301057)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device