FDA Registration
Active
🇹🇼 Taiwan
NON-CHANGE ENTERPRISE CO., LTD.
Reg #: 3010957755
·
FEI: 3010957755
·
Expires 2026
Products
10
Proprietary Names
15
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- NON-CHANGE ENTERPRISE CO., LTD.
- Registration Number
- 3010957755
- FEI Number
- 3010957755
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F.-11, No.12, Ln.609, Sec.5,, Chongxin Rd., Sanchong Dist.,
- City
- New Taipei City
- Country
- TW
Owner / Operator
- Firm Name
- NON-CHANGE ENTERPRISE CO., LTD.
- Operator Number
- 10061014
- Address
- 6F.-11, No.12, Ln.609, Sec.5,, Chongxin Rd., Sanchong Dist.,
- City
- New Taipei City, Taipei, Taiwan
- State
- TW-NWT
- Postal Code
- 24159
- Country
- TW
- Correspondent
- House Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2019-07-30 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2019-07-30 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2019-07-30 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2019-07-30 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2019-07-30 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2019-07-30 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2019-07-30 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2019-07-30 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2019-07-30 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2019-07-30 |
Proprietary Names
Umbilical Cord Clamp
Venturi Mask Kit
Simple Oxygen Mask
Jaw Spreader
Non-rebreathing Mask
Oxygen T-Piece
Nasal Cannula
Naso Airway
Anesthesia Breathing Circuit with accessories(single-use & reusable)
Breathing Bag(latex, latex-free, reusable)
Catheter Mount(single-use & reusable)
Ventilator Breathing Circuit with accessories(single-use & reusable)
Oropharyngeal Airway (Guedel & Berman Airway)
HME
Anesthesia Mask(single-use & reusable)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)