FDA Registration
Active
🇨🇳 China
Tylenol Medical Instruments Co., Ltd.
Reg #: 3013513837
·
FEI: 3013513837
·
Expires 2026
Products
15
Proprietary Names
19
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- Tylenol Medical Instruments Co., Ltd.
- Registration Number
- 3013513837
- FEI Number
- 3013513837
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd Floor, No.10, Xinhua Road, Sanjiao Town,
- City
- Zhongshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181981
Owner / Operator
- Firm Name
- Tylenol Medical Instruments Co., Ltd.
- Operator Number
- 10057256
- Address
- 3rd Floor, No.10, Xinhua Road, Sanjiao Town
- City
- Zhongshan
- State
- Guangdong
- Postal Code
- 528445
- Country
- CN
- Correspondent
- Bin Liu
US Agent
- Business Name
- JIAMEI CONSULTING INC.
- Contact Name
- Peter Yang
- Address
- 418 Broadway Ste R
- City
- Albany
- State
- NY
- ZIP
- 12207
- Country
- US
- [email protected]
- Phone
- 310 2168437
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | Class 2 | Gastroenterology, Urology | No | 2018-05-06 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2018-03-27 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2018-05-06 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-09 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2024-11-18 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2019-03-01 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-03-13 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-11 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2018-05-06 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2018-03-27 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-03-27 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2018-03-27 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2018-03-27 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2018-03-27 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2018-03-27 |
Proprietary Names
Urine collector
Non-rebreath Masks
suction tubing
Tylenolmed, disposal medical mask, non-sterile
Tylenolmed, disposable medical mask, non-sterile
MASS SPECTROMETRY MONITORING LINE CONONECTORS
Tylenol suction handle
Tylenol, Oxygen Masks, Adult standard, Pediatric standard, Adult elongated, Pediatric elongated
Aerosol Mask, model Adult Standard, Pediatric Standard, Adult Elongated, Pediatric Elongated
analyzer, gas, carbon-dioxide, gaseous-phase
Tylenolmed, KN95 Protective Mask, TN-101
Urine bag
ANESTHETIC MASK
Nasal Oxygen Cannulas
Tylenol CO2 Sampling Line
Suction Catheters
AIRWAY, OROPHARYNGEAL
AIRWAY, NASOPHARYNGEAL
Multi-vent Masks
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device