FDA Registration
Active
🇨🇳 China
GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3016171795
·
FEI: 3016171795
·
Expires 2026
Products
4
Proprietary Names
45
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3016171795
- FEI Number
- 3016171795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,
- City
- Huizhou Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Guangdong ENNO Medical Technology Co., Ltd.
- Operator Number
- 10091567
- Address
- No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,
- City
- Huizhou
- State
- Guangdong
- Postal Code
- 516006
- Country
- CN
- Correspondent
- Tammy. Tan
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2024-10-16 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2024-10-16 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2024-10-16 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2024-10-16 |
Proprietary Names
EN-D50, EN-A51, EN-D51, EN-A52, EN-D52, EN-A53, EN-D53, EN-A55, EN-D55, EN-A56, EN-D56, EN-A57, EN-D57, EN-A58, EN-D58,
N-IA006A Pro, EN-IA007A, EN-IA008A, EN-IA009A, EN-IA010A, EN-IA011A, EN-IA012A, EN-IA013A, EN-IA102A, EN-IA102B,
EN-I200 Pro, EN-IA001Pro, EN-IA001A Pro, EN-IA001A, EN-IA001B, EN-IA001C, EN-IA002A, EN-IA003A, EN-IA005A, EN-IA006A,
EN-D20, EN-A21, EN-D21, EN-A22, EN-D22, EN-D22Pro, EN-A23, EN-D23, EN-A24, EN-D24, EN-A25, EN-D25, EN-A26, EN-D26,
EN-N06, EN-N07, EN-N08, EN-N09, EN-N10, EN-N11, EN-N12, EN-N13, EN-N14, EN-N15, EN-N16, EN-N17, EN-N18, EN-N19, EN-N20,
LOOKEE® TrueHear A50 OTC Hearing Aid (Model: A50), LOOKEE® TrueHear A51 OTC Hearing Aid (Model: A51),
Hearing aid, amplifiers with models EN-T100, EN-T100A, EN-T100B, EN-T100C, EN-T200, EN-T201A, EN- T201B, EN-T201D,
EN-T201D OPENFIT, EN-T201H, EN-T201G, EN-T300, EN-T700, EN-T800, EN-T802, EN-T622, EN-T522, EN-T721, EN-T922, EN-T35,
EN-D61, EN-D62, EN-D63, DN-D64, EN-D65, EN-D66, EN-D67, EN-D68, EN-D69, EN-D70, EN-D71, EN-D72, EN-D73, EN-D75,
EN-A8, EN-F2, EN-F4, EN-H3, EN-H8, TC-T002, TC-T009, TC-T010, TC-T015, DCM-350, EN-N01, EN-N02, EN-N03, EN-N04, EN-N05,
EN-N21, EN-N22, EN-N23, EN-N24, EN-N25, EN-N26, EN-N27, EN-N28, EN-N29, EN-N30, EN-N31, EN-N32, EN-N33,
EN-IA102C, EN-D102, EN-IA102E, EN-A15, EN-D15, EN-A16, EN-D16, EN-A17, EN-D17, EN-A18, EN-D18, EN-A19, EN-D19, EN-A20,
EN-A59, EN-D59, EN-A60, EN-D60, EN-RIC-312, EN-RIC-Pro, EN-RIC80, EN-RIC10, EN-OA Li, EN-13 Pro, EN-MCIC80, EN-MCIC10,
EN-D33, EN-A34, EN-D34, EN-A35, EN-D35, EN-A36, EN-D36, EN-A37, EN-D37, EN-A38, EN-D38, EN-A39, EN-D39, EN-A50,
EN-N34, EN-N35, EN-N36, EN-N37, EN-N38, EN-N39, EN-N40, EN-D91,
EN-A27, EN-D27, EN-A28, EN-D28, EN-A29, EN-D29B, EN-D29B Pro, EN-A30, EN-D30, EN-A31, EN-D31, EN-A32, EN-D32, EN-A33,
EN-D76, EN-77, EN-D78, EN-D79, EN-D80, EN-A61, EN-A62, EN-A63, EN-A64, EN-A65, EN-A66, EN-A67, EN-A68, EN-A69, EN-A70,
LOOKEE® TrueHear A58 OTC Hearing Aid (Model: A58), EN-W33, EN-D32Pro
LOOKEE® TrueHear A55 OTC Hearing Aid (Model: A55), LOOKEE® TrueHear A57 OTC Hearing Aid (Model: A57),
EN-C10, PB-B01, PB-B02, PB-B03
EN-A71, EN-A72, EN-A73, EN-A75, EN-A76, EN-A78, EN-A79, EN-A80, EN-C01, EN-C02, EN-C03, EN-C05, EN-C06, EN-C07, EN-C08,
EN-B11, EN-B12, EN-B13, EN-B14, EN-B15, EN-B16, EN-B17, EN-B19, EN-B20, EN-B21, EN-B22, EN-B23.EN-B24.EN-B25, EN-B26,
EN-R001B, EN-R001C, EN-R002, EN-R003, EN-R005, EN-R006, EN-R007, EN-R008, EN-R009, EN-R10, EN-R11, EN-R12, EN-R13,
EN-R102A, EN-R102B, EN-R102C, EN-R102D, EN-R102E, EN-R15, EN-R16, EN-R17, EN-R18, EN-R19, EN-R20, EN-R21, EN-R22,
EN-N25, EN-N26, EN-N27, EN-N28, EN-N29, EN-N30, EN-N31, EN-N32, EN-N33, EN-N34, EN-N35, EN-N36, EN-N37, EN-N38,
EN-P20, EN-P21, EN-P22, EN-P23, EN-P24, EN-P25, EN-P26, EN-P27, EN-P28, EN-P29, EN-P30, EN-P31, EN-P32, EN-P33, EN-P34,
EN-R23, EN-R24, EN-R25, EN-R26, EN-R27, EN-R28, EN-R29, EN-R30, EN-R31, EN-R32, EN-R33, EN-R34, EN-R35, EN-R36, EN-R37,
EN-W18, EN-W19, EN-W20, EN-W21, EN-W22, EN-W23, EN-W24, EN-W25, EN-W26, EN-W27, EN-W28, EN-W29, EN-W30, EN-W31, EN-W32,
EN-P35, EN-P36, EN-P37, EN-P38, EN-P39, EN-P50, EN-P51, EN-P52, EN-P53, EN-P55, EN-P56, EN-P57, EN-P58, EN-P59, EN-P60,
EN-R38, EN-R39, EN-R50, EN-R51, EN-R52, EN-R53, EN-R55, EN-R56, EN-R57, EN-R58, EN-R59, EN-R60, EN-R100, EN-R200,
EN-T002, EN-T009, EN-T010, EN-T015, DCM-450, EN-N01, EN-N02, EN-N03, EN-N04, EN-N05, EN-N06, EN-N07, EN-N08, EN-N09,
EN-P10, EN-P11, EN-P12, EN-P13, EN-P102A, EN-P102B, EN-P102C, EN-P102D, EN-P102E, EN-P15, EN-P16, EN-P17, EN-P18,EN-P19,
EN-P100, EN-P200, EN-P201, EN-P300, EN-P700, EN-P800, EN-P802, EN-P622, EN-P522, EN-P721, EN-P922, EN-R01, EN-R001,
EN-N39, EN-N40, ion pro , LR0010, EN-J10, EN-J20, EN-R03-01, EN-R03-02, EN-R03-03, EN-R03-04, CHE-S-001, EN-P90,
EN-W33, EN-W34, EN-W35, EN-W36, EN-W37, EN-W38, EN-W39, EN-W50, EN-W51, EN-W52, EN-W53, EN-W55, EN-W56, EN-W57, EN-W58,
EN-W009, EN-W10, EN-W11, EN-W12, EN-W13, EN-W102A, EN-W102B, EN-W102C, EN-W102D, EN-W102E, EN-W15, EN-W16, EN-W17,
EN-R201, EN-R300, EN-R700, EN-R800, EN-R802, EN-R622, EN-R522, EN-R721, EN-R922, EN-W80, EN-W81, EN-W91,
EN-B01, EN-B02, EN-B03, EN-B04, EN-B05, EN-B06, EN-B07, EN-B08, EN-B09, EN-B10
Hearing aid, amplifiers with models EN-W001, EN-W001B, EN-W001C, EN-W002, EN-W003, EN-W005, EN-W006, EN-W007, EN-W008,
EN-N10, EN-N11, EN-N12, EN-N13, EN-N14, EN-N15, EN-N16, EN-N17, EN-N18, EN-N19, EN-N20, EN-N21, EN-N22, EN-N23, EN-N24,
EN-H001, EN-H007, EN-H008, EN-P001, EN-P001B, EN-P001C, EN-P002, EN-P003, EN-P005, EN-P006, EN-P007, EN-P008, EN-P009,
EN-W59, EN-W60, EN-W100, EN-W200, EN-W201, EN-W300, EN-W700, EN-W800, EN-W802, EN-W622, EN-W522, EN-W721, EN-W922,
EN-B27, EN-B28, EN-B29, EN-B30, PB-C01, PB-C02
Hearing Aid/Amplifier DCM-110
Wireless Bluetooth Hearing Aid DCM-220, PB-A01, PB-A02, PB-A03, PB-A04, PB-A05
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device