FDA Registration
Active
🇨🇳 China
Shenzhen Heearly Technology Co.,Ltd.
Reg #: 3016458459
·
FEI: 3016458459
·
Expires 2026
Products
13
Proprietary Names
28
Establishment Types
3
Classifications
13
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Registration Details
- Registration Name
- Shenzhen Heearly Technology Co.,Ltd.
- Registration Number
- 3016458459
- FEI Number
- 3016458459
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4th Fl, Bldg B, Yangfeng Intelligent Technology Park,, Changcheng Rd, Shuitian Community, Shiyan Subdistrict
- City
- Bao an District, Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Yajiebao Technology Development Co., Ltd.
- Operator Number
- 10062334
- Address
- Room 607, Building 2, Sanhe International, Laiwushan New Village, Laiwushan Community, Dalang Subdistrict, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518108
- Country
- CN
- Correspondent
- Xilai Wang
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 |
|---|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2026-01-14 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2025-03-14 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | Class 1 | Dental | No | 2025-03-14 |
| Ear Irrigation Kit | OGQ | Class 1 | General Hospital | No | 2025-03-14 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2026-03-04 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2026-01-14 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2020-01-14 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2020-01-14 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2025-03-14 |
| Floss, Dental | JES | Class 1 | Dental | No | 2025-03-14 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2020-01-14 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2021-05-12 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-01-14 |
Proprietary Names
Ultrasonic Cleaner T3, T3U, T5, T5U, T7, T8, T9, T10
Ultrasonic Cleaning Machine: SQ8638, SQ8639, SQ8740, SQ8750
BT-001; BT-002
Y3 Plus; Y1; Y1b; Y3; Toothbrush sterilizer: SQ8753, SQ8756
ER-200; ER-2306; ER-2308; ER-2309
Razor, Women's razor, Razor head, Electric Nose Hair Trimmer; G3, G5, G6, G7, G8
Golf Cleaning Brush: GF-001, GF-002, GF-003
CY-1913; CY-1914; CY-1915; CY-1916; CY-1917; CY-1918; CY-1919; CY-1920; CY-1921; CY-1922; CY-1923; CY-1925; CY-1928;
360E, 360F, HF160A, HF190A, HF230A, HF175, W05, W06, OC1200, HF90, YB8110, YB8130, YB8300, SQ8568, X3, P9
CY-1901; CY-1902; CY-1903; CY-1903B; CY-1904; CY-1905; CY-1906; CY-1907; CY-1908; CY-1909; CY-1910; CY-1911; CY-1912;
Oral Irrigator; Water Flosser; Dental Water Jet: CY-2601, CY-2602, CY-2603, CY-2605, CY-2606, 360A, 360B, 360C, 360D,
CY-2202; CY-2203; CY-2205; CY-2206; CY-2207; CY-2208; CY-2209; CY-801; CY-803; CY-201; CY-202; CY-205; CY-206;
CY-820; CY-821; CY-825; CY-826; HF160A; HF175; HF176; HF190A; HF230A; W05; W05-1; W05-2; W06; OC1200
NW-300; NW-301; NW-303; NW-304; NW-304B; NW-305; NW-310; NW-318; NW-320; NW-321; NW-322; NW-323; NW-326; NW-328; NW-329;
NW-330; NW-331; NW-332; HF160; HF190; HF230; HF320; HF168; HF600
Nasal Irrigation: NW-303B, PNC-01, SN-2503, 360G, 360H, 360K, HF160, HF190, HF230, HF320, HF168, HF600
TE-001; TE-002
DY-001; DY-002; DY-003; DY-004
Electric teeth cleaner: M3, M3U, M5, M5U, M7, M7U, M8, M8U, M9, M9U, M10, M11, M12, M13, T3, T3U, T5, T5U, T7, T8, T9,
CY-1913B; XY-002; CY-1926; CY-1926B; CY-2201; CY-2201B; CY-2305; CY-2305B; CY-2306; CY-2308; CY-1921; JY-001; SX-001;
SZ-002; CY-1926C; CY-1926D; CY-2305D; CY-2306, CW-001; CW-002; F518; F519; F619; F818; F818P
M10, M11, M12, M13, T3, T3U, T5, T5U, T7, T8, T9, T10;
Electric Tooth Polisher, Tooth Polisher, Multifunetional Tooth Polisher: SOL049.SOL050.T9, M7, M7U, M11
Sonic Toothbrush, Pet Electric Toothbrush: CW-001, CW-002, F518, F519, F619, F818, F818P, Ex-05, Ex-05A, Ex-05B, Ex-05C,
Ex-05D, Ex-05E, F518A, F518B, F519 A3, A3S, F818, T5
M10, M11, T3, T3U, T5, T5U, T7, T8, T9, T10
Electric dental scaler, Dental calculus remover, Electric teeth cleaner: M3, M3U, M5, M5U, M7, M7U, M8, M8U, M9, M9U,
Bath Jet Spa: SL-2501, SL-2502, SL-2503; Beauty Device: Glo-06, Glo-06A, Glo-06B, Glo-06C, Glo-06D, Glo-06E
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