FDA Registration
Active
🇲🇾 Malaysia
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Reg #: 8044169
·
FEI: 1000283452
·
Expires 2026
Products
23
Proprietary Names
45
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- PLAXTRON INDUSTRIAL (M) SDN. BHD.
- Registration Number
- 8044169
- FEI Number
- 1000283452
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PLOT 28, KAWASAN PERUSAHAAN, JELAPANG 2, FTZ
- City
- IPOH Perak
- Country
- MY
Owner / Operator
- Firm Name
- PLAXTRON INDUSTRIAL (M) SDN. BHD.
- Operator Number
- 9005976
- Address
- PLOT 28, KAWASAN PERUSAHAAN, JELAPANG 2, FTZ
- City
- IPOH, PERAK
- State
- MY-NOTA
- Postal Code
- 30020
- Country
- MY
- Correspondent
- JAY - WANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2012-01-17 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2016-04-26 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2006-03-24 |
| Meter, Airway Pressure (Inspiratory Force) | BXR | Class 2 | Anesthesiology | No | 2007-06-26 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2009-10-28 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2010-08-27 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2010-08-26 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2012-01-17 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 1992-08-04 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2011-07-21 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2015-02-13 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2011-05-13 |
| Resuscitator, Manual, Non Self-Inflating | NHK | Class 2 | Anesthesiology | No | 2007-11-26 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2014-04-22 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2012-01-17 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2012-01-17 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2006-09-21 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2006-03-24 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 1992-08-04 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2007-11-26 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2006-09-21 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2010-08-26 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-08-04 |
Proprietary Names
AIRWAY PRESSURE MANOMETER
RESUSA-TEE
TOOTH PROTECTOR
Airway Pressure(Inspiratory Force)
METER
Flow-Safe CPAP System
CPAP
EZ-FLOW
Anesthesia Mask
Anesthesiology Mask
CPR BAG (REUSABLE)
CPR BAG (DISPOSABLE W/EXPANDABLE RESERVOIR)
Oxygen Mask
Peep Valve
Resistex
Expiratory Resistance Exerciser
ShurClear
DISPOSEAL
Disposeal Mouth Piece
Hyperinflation
(T-Piece Resuscitator)
NEO TEE
Pump Assembly w/ Private
Hand Pump
Anesthesia Breathing Circuit
MINI STATCO2 CO2 DETECTOR
LMA Fastrach¿ SU
LMA Unique¿
LMA Flexible¿ SU
INTUBATING LARYNGEAL AIRWAY
Laryngeal Mask
MULTI CONNECTOR
,OMNILINK MALE
CONNECTOR DISCONNECT WEDGE
EMALE EXTENSION TUBE
Nose Clip
STATCO2 DETECTOR
BACTERIA FILTER
EZFLOW MAX CONTINUOUS NEBULIZER
CPR BAG ( DISPOSABLE)
BOUGIE
STYLET BLOCKER AIRWAY
OXYGEN TUBING
ANESTHESIA TUBING
Cylinder Wrench
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device