Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016171795

FEI Number

3016171795

Entity Name

GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Huizhou Guangdong, CN

Establishment Address

No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,, Huizhou Guangdong 516006, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Guangdong ENNO Medical Technology Co., Ltd. (Owner Number: 10091567)

Owner / Operator Contact Address

No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,, Huizhou, CN-GD 516006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2024-10-16
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2024-10-16
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2024-10-16
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2024-10-16

Official Correspondent

Tammy. Tan

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Guangdong ENNO Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016171795. Last updated year: 2026. Please use registration number 3016171795 when referencing this establishment in official correspondence.