FDA Registration
Active
🇨🇳 China
VONCARE MEDICAL DEVICE CO LTD
Reg #: 3011307234
·
FEI: 3011307234
·
Expires 2026
Products
4
Proprietary Names
17
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- VONCARE MEDICAL DEVICE CO LTD
- Registration Number
- 3011307234
- FEI Number
- 3011307234
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2nd South Road, District 8, Shiwan Town
- City
- Huizhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212191
Owner / Operator
- Firm Name
- VONCARE MEDICAL DEVICE CO LTD
- Operator Number
- 10047792
- Address
- 2nd South Road, District 8, Shiwan Town
- City
- Huizhou
- State
- Guangdong
- Postal Code
- 516127
- 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 |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2014-11-02 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-12-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-24 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2021-12-27 |
Proprietary Names
Disposable Cardiology Electrodes BBCARE-Ag/Agcl: BB231550NS, BB231560NS, BB234050NS, BB234060NS, BB231550FL, BB234050FL
Disposable Cardiology electrodes BBCARE-Ag: BB231560NV, BB234060NV, BB201560NV, BB204060NV, BB301560NR, BB234035NV
Disposable Cardiology electrodes BBCARE-Ag: BB231550NV, BB234050NV, BB201550NV, BB204050NV, BB301550NR, BB304050NR
Disposable Cardiology electrodes BBCARE-RADIOTRANSLUSCENT: BBTR231550, BBTR234050, BBTR321550, BBTR324050, BBTR231560
Disposable Cardiology electrodes BBCARE-RADIOTRANSLUSCENT:BBTR234060, BBTR321560, BBTR324060
Disposable Cardiology electrodes BBCARE-Ag:BB204035NV, BB304035NR, BB304050NG, BB304035NG, NG-NO GEL
Disposable Cardiology Electrodes BBCARE-Ag/Agcl: BB231560FL, BB234060FL,BB234034NS, BB234035FL
Disposable Snap Cardiology Electrodes: T716,T707,T707L,T706M,T709,T709RT
Adhesive Electrode
Face Mask VC-001-KN90; VC-001-KN95
Disposable Isolation Cloth VC-002-DC-011, VC-002-DC-012, VC-002-DC-013, VC-002-DC-014, VC-002-DC-015
Isolation Mask VC-001-KN90; VC-001-KN95
Disposable Isolation Cloth VC-002-DC-016, VC-002-DC-017, VC-002-DC-018, VC-002-DC-019, VC-002-DC-020
Disposable Isolation Cloth VC-002-DC-006, VC-002-DC-007, VC-002-DC-008, VC-002-DC-009, VC-002-DC-010
Disposable Isolation Cloth VC-002-DC-001, VC-002-DC-002, VC-002-DC-003, VC-002-DC-004, VC-002-DC-005
Video Laryngoscope
VL01; VL02
Establishment Types
Manufacture Medical Device