FDA Registration
Active
🇨🇳 China
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
Reg #: 3006621386
·
FEI: 3006621386
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3006621386
- FEI Number
- 3006621386
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.89 Taoyuan East Rd, Nanhai
- City
- Foshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K070451
Owner / Operator
- Firm Name
- Guangdong Baihe Medical Technology Co., Ltd.
- Operator Number
- 9097900
- Address
- No.89, Taoyuan East Rd, Nanhai
- City
- Foshan
- State
- Guangdong
- Postal Code
- 528225
- Country
- CN
- Correspondent
- Rongzhang Cen
US Agent
- Business Name
- PUREVISION AI, INC. (DBA PURE GLOBAL)
- Contact Name
- Bryan Wong
- Address
- 111 Town Square Pl Ste 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 888 7681688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2023-07-21 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-09-14 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2011-12-20 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2013-12-08 |
Proprietary Names
CMC Wound Dressing
ABLE CENTRAL VENOUS CATHETER
Disposable Hemodialysis Access Catheter Set
Disposable Silicone Foley Catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device