FDA Registration
Active
🇨🇳 China
CHANGSHU BEYOND MEDICAL DEVICE CO., LTD.
Reg #: 3010806410
·
FEI: 3010806410
·
Expires 2026
Products
9
Proprietary Names
21
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- CHANGSHU BEYOND MEDICAL DEVICE CO., LTD.
- Registration Number
- 3010806410
- FEI Number
- 3010806410
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 386 Changkun Road, 215500, Changshu City
- City
- Changshu Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- ChangShu Beyond Medical Device Co., Ltd.
- Operator Number
- 10046360
- Address
- No. 386 Changkun Road, 215500, Changshu City
- City
- Changshu
- State
- Jiangsu
- Postal Code
- 215500
- Country
- CN
- Correspondent
- Jianxin Zhu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-04-10 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2014-03-12 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2017-06-14 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2019-09-25 |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | Class 1 | Gastroenterology, Urology | No | 2014-03-12 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2016-09-11 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2014-03-12 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-10 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-04-10 |
Proprietary Names
Protective Eyewear
Eye shield goggles
safety goggle
Beyond urine bags
Infant Urine Bags
Leg Urine Bags
Urine Meter
leg urine bag
DrainageCatheters
Wound Drainage
External catheter
Urinal
beyond
wound drainage reservoir
wound Drainage reservoir
reservoir kit
preventive suit
Non-Surgical Isolation Gown
Isolation Gown
non woven face mask
3ply face mask
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)