FDA Registration
Active
🇹🇼 Taiwan
ENTER MEDICAL CORPORATION
Reg #: 3003902679
·
FEI: 3003902679
·
Expires 2026
Products
21
Proprietary Names
35
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- ENTER MEDICAL CORPORATION
- Registration Number
- 3003902679
- FEI Number
- 3003902679
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 66-5, Yao Tzu Chu, Tsai Kung Village, Hsin Kang Township
- City
- Chiayi County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K152521
Owner / Operator
- Firm Name
- ENTER MEDICAL CORPORATION
- Operator Number
- 9054547
- Address
- No.66-5,Yao Tzu Chu, Tsai Kung Village, Hsin Kang Township
- City
- Chiayi County
- State
- TW-CYQ
- Postal Code
- 61642
- Country
- TW
- Correspondent
- TSUNG FU KUO
US Agent
- Business Name
- J & F Technology Service
- Contact Name
- Fanny Zhao
- Address
- 19838 Moon Shadow Circle
- City
- Walnut
- State
- CA
- ZIP
- 91789
- Country
- US
- [email protected]
- Phone
- 909 5100201
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2004-06-07 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2004-06-07 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2020-05-14 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2021-10-24 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2021-10-24 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2004-06-07 |
| Clip, Lens, Trial, Ophthalmic | HPB | Class 1 | Ophthalmic | No | 2024-11-14 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2021-10-24 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2014-05-16 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2021-10-24 |
| Screw, Oral | KBW | Class 1 | Ear, Nose, Throat | No | 2004-06-07 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2004-06-07 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2003-01-02 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2025-12-18 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2021-10-24 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2021-10-24 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2018-01-25 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2007-12-01 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2004-06-07 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2004-06-07 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2021-10-24 |
Proprietary Names
ShineBall
GTC2025 1/2" (Tube)
EnterMed Aspirating Tubing
Disposable Vacuum Tubing
Shine ball Aspirating Tubing
Medway Aspirating Tubing
GTC2024 3/8 (Tube)
ENTER
seal rite valve
humidifier, non-direct patient interface (home-use)
strap, head, gas mask
Dive Mask OPTICAL LENS
drain, tee (water trap)
THE LIFEGUARD
set, tubing and support, ventilator (w harness)
ENTER OXYGEN MASK
Airway Adapter
Double Swivel Elbow Connector
Catheter Mount and Connectors
Oxygen T-piece
Catheter Mount
PN-500-XX
PN-2025-XX
Swivel Oxygen Connector
PN-2024-XX
Oxygen Connector
Oxygen Tube Adapter
Airway Connector
Elbow Connector
tubing, pressure and accessories
bag, reservoir
Endoscopic Bite Block
Enter
SHINE BALL
circuit, breathing (w connector, adaptor, y piece)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device