FDA Registration
Active
🇨🇳 China
Guangdong MacroLux Medical Technology Co., Ltd.
Reg #: 3035710892
·
FEI: 3035710892
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Guangdong MacroLux Medical Technology Co., Ltd.
- Registration Number
- 3035710892
- FEI Number
- 3035710892
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 501, Building 6, No.4, Xinxi Road, Songshan Lake High-Tech Industrial Development Zone
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- MacroLux Medical Technology Co., Ltd.
- Operator Number
- 10089857
- Address
- 301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518107
- Country
- CN
- Correspondent
- Linbin Ye
US Agent
- Business Name
- ICAS Biologics Co., Ltd.
- Contact Name
- Sarah Galemmo
- Address
- 20 Via Lucca D310
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 661 8033155
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-06-12 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2025-08-26 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-08-20 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-04-06 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-01-16 |
Proprietary Names
BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)
ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
Trolley
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B
CoralWell, NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B,
NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B,
LoopView® Single-Use Digital Flexible Bronchoscope (B38-G, B38-CG, B50-G, B50-CG, B58-G, B58-CG),
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
CoralView® Single-use Digital Flexible Ureteroscope (U10, U10-B, U10-BR, U20, U20-B, U20-BR)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device