FDA Registration
Active
🇹🇼 Taiwan
GREAT GROUP MEDICAL CO LTD.
Reg #: 3008567544
·
FEI: 3008567544
·
Expires 2026
Products
9
Proprietary Names
9
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- GREAT GROUP MEDICAL CO LTD.
- Registration Number
- 3008567544
- FEI Number
- 3008567544
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.168, Xingong 2nd Rd., Tianzhong Township
- City
- Changhua County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K210352
Owner / Operator
- Firm Name
- Great Group Medical Co Ltd.
- Operator Number
- 10045498
- Address
- No.168, Xingong 2nd Rd., Tianzhong Township
- City
- Changhua County
- State
- TW-CHA
- Postal Code
- 52046
- Country
- TW
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2013-11-24 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2021-04-19 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2020-08-19 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2013-11-24 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2013-11-24 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2021-03-04 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2013-11-24 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2013-11-24 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2013-11-24 |
Proprietary Names
Nonrebreathing mask
GGM Disposable Heater Wire Breathing Circuit
Respiratory Humidifier, Models VH-2100, VH2600A, and VH-2600
Ventilator tubing
Respiratory gas humidifier
GGM Breathing Circuit Bacterial Filter
Therapeutic humidifier for home use
Nasal oxygen cannula
Artificial nose
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)