FDA Registration
Active
🇭🇰 Hong Kong
VINCENT MEDICAL MANUFACTURING. CO., LTD.
Reg #: 1000604079
·
FEI: 1000604079
·
Expires 2026
Products
45
Proprietary Names
17
Establishment Types
3
Classifications
45
Registration Details
- Registration Name
- VINCENT MEDICAL MANUFACTURING. CO., LTD.
- Registration Number
- 1000604079
- FEI Number
- 1000604079
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FLAT/RM B2,7/F,HANG FUNG INDUSTRIAL BUILDING, PHASE 2,2G HOK YUEN STREET,HUNG HOM
- City
- KOWLOON
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K101380
Owner / Operator
- Firm Name
- VINCENT MEDICAL MANUFACTURING. CO., LTD.
- Operator Number
- 10041038
- Address
- FLAT/RM B2, 7/F, HANG FUNG INDUSTRIAL BUILDING, PHASE 2,2G HOK YUEN STREET,HUNG HOM,
- City
- KOWLOON
- State
- HK-NOTA
- Postal Code
- --
- Country
- HK
- Correspondent
- Thomas Chan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2012-06-14 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2015-02-02 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2012-06-14 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2014-09-15 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2014-09-15 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2014-09-15 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2014-09-15 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2014-09-15 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2014-09-15 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2014-09-15 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2014-09-15 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2014-09-15 |
| Computer, Oxygen-Uptake | BZL | Class 2 | Anesthesiology | No | 2014-09-15 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2012-06-14 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2015-09-10 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2012-06-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2018-05-14 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2025-06-02 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2017-01-10 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2020-07-26 |
| Conserver, Oxygen | NFB | Class 2 | Anesthesiology | No | 2013-01-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-06-14 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2013-02-03 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2024-11-10 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2024-11-10 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2012-06-14 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2013-01-31 |
| Device, Positive Pressure Breathing, Intermittent | NHJ | Class 2 | Anesthesiology | No | 2019-08-01 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2019-08-01 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2019-08-01 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2019-08-01 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2013-01-31 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2014-11-18 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2016-06-01 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2013-01-31 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2012-06-14 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2012-06-14 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2012-06-14 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2013-05-25 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2013-01-31 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2017-03-28 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2012-11-22 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2012-06-14 |
Proprietary Names
Inspired Ventilation Circuits including Adult/ Prediatric ventilaation circuit including PVC tube, pressure monitor line
Inspired Medical nCPAP Patient Interface including Adult / Pediatric Silicone Circuit including resuable catheter
Inspired Medical Limbo Circuit iincluding connectors
Inspired Meidcal Coaxial Circuit including Coaxial anesthesia circuit, expanable tube, connectors
Inspired Medical Smoothbore Ventilation Circuits including Adult Smoothbore cirucit including Adult Siingle Limb, exhala
Inpsired Medical Adult Anaesthesia Breathing System including drapable/expandable tubing, connectors, spare limb
Inpsired Medical Prediatric Anaesthesia Breathing System including hoses, connectors, spare limb
Inspired Medical Reusable Hytrel Circuits including Adult single / dual limb hytrel circuit, exhalation valve
Adult (22mm) Single limb Smoothbore + 3 Way exhalation valve (VM version)
Adult (22mm) Single limb corrugated + 3 Way exhalation valve (VM version)
Pediatric (15mm) Single limb corrugated + 3 way exhalation valve (VM version)
Pediatric (15mm) Single limb Smoothbore + 3 way exhalation valve (VM version)
BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m
Pressure Hose Assemblies (DISS)
Air Cushion Masks for neonate, infant, pediatric, child, small adult, large adult
RW Resuscitaire
Inspired Medical breathing bag: 0.5L / 1L / 2L / 3L
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)