FDA Registration
Active
🇨🇳 China
W02-01001, W02-01002, W02-01003,W02-01004, W02-01005, Wyltec
Reg #: 9680638
·
FEI: 3005667208
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- CARDICARE COMPANY, LTD.
- Registration Number
- 9680638
- FEI Number
- 3005667208
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 27 Huashan Road Gaochun Economy Zone
- City
- NANJING Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- CARDICARE COMPANY, LTD.
- Operator Number
- 9010325
- Address
- 9 YAN AN ROAD, WU SHAN PLAZA TOWN, UNIT 7003
- City
- HANGZHOU
- State
- Zhejiang
- Postal Code
- 310002
- 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 |
|---|---|---|---|---|---|
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 1994-05-06 |
Proprietary Names
W02-01001, W02-01002, W02-01003,W02-01004, W02-01005, Wyltec
MANUAL STETHOSCOPE
Model ST-SH-001,ST-DH-001,ST-SR-001, ST-CARD-002
10-404-010,10-404-020,10-404-030,10-404-070,10-408-093,10-414-010,10-414-020,10-414-030,10-414-050,10-414-070
10-429-200,10-429-240,10-429-250,10-422-010,10-426-010,10-426-020,10-426-050,10-426-070,10-426-080,10-426-110
10-419-050,10-419-070,10-419-080,10-419-110,10-419-120,10-419-130,10-419-150,10-419-160,10-419-200,10-419-240
10-419-250,10-419-3601,10-419-3612,10-419-3620,10-429-010,10-429-020,10-429-030,10-429-070,10-429-110,10-429-150
10-414-0201,10-414-0701,10-414-0801,10-414-1501,10-414-160110-414-2001,10-416-0501,10-419-010,10-419-020
10-428-250,10-446-020,10-402-020,10-440-020,10-445-02010-446-020,10-448-010,10-448-130
10-426-120,10-426-150,10-426-200,10-426-250,10-426-0101,10-426-0701,10-426-0801,10-426-1501,10-426-1601,10-426-2001
10-428-010,10-428-020,10-428-030,10-428-050,10-428-070,10-428-080,10-428-130,10-428-220,10-428-240
10-414-080,10-414-110,10-414-120,10-414-130,10-414-150,10-414-160,10-414-200,10-414-240,10-414-250,10-414-0101
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device