FDA Registration
Active
🇹🇼 Taiwan
ASIA CONNECTION CO., LTD.
Reg #: 3006157842
·
FEI: 3006157842
·
Expires 2026
Products
53
Proprietary Names
52
Establishment Types
3
Classifications
53
Registration Details
- Registration Name
- ASIA CONNECTION CO., LTD.
- Registration Number
- 3006157842
- FEI Number
- 3006157842
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 16F-1, No.16, Jian Ba Road, Chung Ho District,
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K020474
Owner / Operator
- Firm Name
- ASIA CONNECTION CO., LTD.
- Operator Number
- 10022874
- Address
- 16F-1, No.16, Jian Ba Road,, Chung Ho District
- City
- New Taipei City
- State
- TW-NOTA
- Postal Code
- 235603
- Country
- TW
- Correspondent
- Sam Lee
US Agent
- Business Name
- FDAbasics LLC
- Contact Name
- Jerry Doane
- Address
- 15815 Sw 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-25 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2010-08-30 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2010-12-17 |
| Device, Inflation, Middle Ear | MJV | Class U | Unknown | No | 2021-05-10 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2012-04-20 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2012-12-18 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2015-03-16 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2015-03-16 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2008-10-28 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2013-09-03 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2007-10-17 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2013-04-15 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2007-10-17 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2014-02-11 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2008-01-17 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2008-10-28 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2010-10-15 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2011-03-03 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2007-10-17 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2017-12-11 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2019-11-29 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2020-08-12 |
| Board, Cardiopulmonary | FOA | Class 1 | General Hospital | No | 2012-05-02 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2007-10-17 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-08-24 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2014-02-11 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2010-12-03 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2013-04-15 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2007-10-17 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2012-07-31 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2013-08-12 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2013-06-02 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2016-07-13 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2008-10-28 |
| Transducer, Gas Pressure | BXO | Class 1 | Anesthesiology | No | 2010-09-13 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2020-04-15 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2012-05-17 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2020-10-19 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2020-12-17 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2007-10-17 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2012-05-02 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2019-12-17 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2009-12-17 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2009-12-17 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2008-05-18 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2012-04-03 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2008-01-17 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2008-05-07 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2008-10-28 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2015-06-23 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2019-05-13 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2008-05-19 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2014-02-11 |
Proprietary Names
N95 Particulate Respirators
Nebulizer Kit
ME4437 Egg-shaped Manual Nasal Aspirator
ME4438 Acorn-shaped Manual Nasal Aspirator
ME8202X Battery Operated Nasal Aspirator
ME4439 Pen-shaped Manual Nasal Aspirator
MS001 Auto-Bulb Manual Nasal Aspirator
MS002 Hand Pump Manual Nasal Aspirator
Eustachi Ear Pressure Relief Device
Instand Hot Pack, Instant Cold Pack
Instant ear thermometer, Fahrenheit & Celsius scales
Twin port mask with one valve
Guedel airways
Airways
Berman airways
Two-Piece Connector
Bandage Scissors
Cuffed/ Uncuffed Endotracheal Tube with Style
Cuffed/Uncuffed Endotracheal Tube
Mouthpiece, breathing
AIRWAY, NASOPHARYNGEAL
Manual Stethoscope
Endotracheal tube
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Oxygen Connecting Tube
CPR Board
Thermometer, Electronic, Clinical
Pocket Resuscitator
CPR mask
Chemo Gown; Coverall with tape; Disposable Coverall; Disposable Isolation Gown
Tube Type Flow Meter
Splint
Air cushion mask
Silicone stomach tube
Compressor Nebulizer
Disposable PVC Resuscitator, Disposable PEEP Valve, Disposable Manometer
Polymer patient examination gloves
Body Strap Kit
Head Harness for child
Head Harness for infat
Head Harness for adult
Oxygen cylinder, Oxygen regulator, Oxygen Flow meter
Suction Connecting Tube
Yankauer Handle
Nasal Cannula
blood pressure cuff
Manual Suction Pump
Suction Catheter
MS002 Hand Pump Nasal Aspirator
HMEF
High Concentration Oxygen mask
Venturi Mask
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)