FDA Registration
Active
🇨🇳 China
Home 30 Plus, Home 30 Ultral, Home 30 SE, Home 30 Mini, Home 30 Power, Home 30 Turbo, Home 30 Eco, Home 30 All
Reg #: 3016170496
·
FEI: 3016170496
·
Expires 2025
Products
1
Proprietary Names
46
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEIFENG ZHIZAO(SHENZHEN)TECHNOLOGY CO.,LTD
- Registration Number
- 3016170496
- FEI Number
- 3016170496
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 1205, Building 1, Vanke Xingchen Building, Xinqiao Street, Bao an District
- City
- shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Heifeng Zhizao(Shenzhen)Technology Co.,Ltd
- Operator Number
- 10061660
- Address
- Floor 1, Building 6, Gangzai Street, Furong Industrial Zone, Xiangshan Community,, Xinqiao Street, Bao an District
- City
- shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- quan lai lv
US Agent
- Business Name
- REP America LLC
- Contact Name
- Ben XU
- Address
- 350 Terry St Ste 200
- City
- Longmont
- State
- CO
- ZIP
- 80501
- Country
- US
- [email protected]
- Phone
- 719 2013314
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2019-11-06 |
Proprietary Names
Home 30 Plus, Home 30 Ultral, Home 30 SE, Home 30 Mini, Home 30 Power, Home 30 Turbo, Home 30 Eco, Home 30 All
bebird 3 B31R SE, bebird 3 B31R Ultra,bebird 3 B31R+,bebird 3 B31R Pro+, EarSight SE B31R,EarSight Plus B31R
Note5,Note5 Pro,Note5 Pro Max,Note5 Plus,Note5 Max,Note5 S,Note5 SE
X3,X3 Pro,X3 Pro Max,X3 Plus,X3 Max,X3 S,X3 SE,X3 Ultra,X3+,X3 Pro+,X3 CC
bebird 3 I35R SE, bebird 3 I35R Ultra,bebird 3 I35R+,bebird 3 I35R Pro+, EarSight SE I35R,EarSight Plus I35R
C3,C3 Pro,C3 Pro Max,C3 Plus,C3 Max,C3 S,C3 SE,C3 Ultra,C3+,C3 Pro+,C3 CC
K10,K10 Pro,K10 Pro Max,K10 Plus,K10 Max,K10 S,K10 SE
W3,W3 Pro,W3 Pro Max,W3 Plus,W3 Max,W3 S,W3 SE,W3 Ultra,W3+,W3 Pro+,W3 CC
P30,P30 Pro,P30 Pro Max,P30 Plus,P30 Max,P30 S,P30 SE,P30 Ultra,P30+,P30 Pro+,P30 CC
Q3,Q3 Pro,Q3 Pro Max,Q3 Plus,Q3 Max,Q3 S,Q3 SE
D39R,D39R Pro,D39R Pro Max,D39R Plus,D39R Max, D39R S,D39R SE,D39R Ultra,D39R+,D39R Pro+
X0,X0 Pro,X0 Pro Max,X0 Plus,X0 Max,X0 S,X0 SE
X1,X1 Pro,X1 Pro Max,X1 Plus,X1 Max,X1 S,X1 SE,X1 Ultra,X1+,X1 Pro+,X1 CC
X17,X17 Pro,X17 Pro Max,X17 Plus,X17 Max,X17 S,X17 SE,X17 Ultra,X17+,X17 Pro+,X17 C
T15,T15 Pro,T15 Pro Max,T15 Plus,T15 Max,T15 S,T15 SE,T15 Ultra,T15+,T15 Pro+,T15 CC
B31R,B31R Pro,B31R Pro Max,B31R Plus,B31R Max, B31R S,B31R SE,B31R Ultra,B31R+,B31R Pro+
M9,M9 Pro,M9 Pro Max,M9 Plus,M9 Max,M9 S,M9 SE,M9 Ultra,M9+,M9 Pro+,M9 CC
R3,R3 Pro,R3 Pro Max,R3 Plus,R3 Max,R3 S,R3 SE,R3 Ultra,R3+,R3 Pro+,R3 CC
Home 7, Home 7 Max, Home 7 Ultra, Home 7 Plus, Home 7X, Home 7S, Home 7E, Home 7 SE, Home 7C
Note3,Note3 Pro,Note3 Pro Max,Note3 Plus,Note3 Max,Note3 S,Note3 SE,Note3 Ultra,Note3+,Note3 Pro+,Note3 CC
B2,B2 Pro,B2 Pro Max,B2 Plus,B2 Max,B2 S,B2 SE,B2 Ultra,B2+,B2 Pro+,B2 CC
T5,T5 Pro,T5 Pro Max,T5 Plus,T5 Max,T5 S,T5 SE,T5 Ultra,T5+,T5 Pro+,T5 CC
bebird 3 D39R,bebird 3 D39R Pro,bebird 3 D39R Pro Max, bebird 3 Plus D39R ,bebird 3 D39R Max,bebird 3 D39R S
R1,R1 Pro,R1 Pro Max,R1 Plus,R1 Max,R1 S,R1 SE,R1 Ultra,R1+,R1 Pro+,R1 CC
bebird 3 R37R,bebird 3 R37R Pro,bebird 3 R37R Pro Max, bebird 3 Plus R37R ,bebird 3 R37R Max,bebird 3 R37R S
D3,D3 Pro,D3 Pro Max,D3 Plus,D3 Max,D3 S,D3 SE,D3 Ultra,D3+,D3 Pro+,D3 CC
bebird 3 R37R SE, bebird 3 R37R Ultra,bebird 3 R37R+,bebird 3 R37R Pro+, EarSight SE R37R,EarSight Plus R37R
bebird 3 B31R,bebird 3 B31R Pro,bebird 3 B31R Pro Max, bebird 3 Plus B31R ,bebird 3 B31R Max,bebird 3 B31R S
OTOSCOPE
35R,I35R Pro,I35R Pro Max,I35R Plus,I35R Max, I35R S,I35R SE,I35R Ultra,I35R+,I35R Pro+
K3, K3 Pro, K3 Pro Max, K3 Plus, K3 Max, K3 S, K3 SE, K3 Ultra, K3+, K3 Pro+
Home 30, Home 30X, Home 30S, Home 30E, Home 30C, Home 30H, Home 30P, Home 30 Pro, Home 30 Max, Home 30 Pro Max
A2,A2 Pro,A2 Pro Max,A2 Plus,A2 Max,A2 S,A2 SE,A2 Ultra,A2+,A2 Pro+,A2 CC
T3 Pro, T3 Pro Max, T3 Plus, T3 Max, T3 S, T3 SE, T3 Ultra, T3+, T3Pro+
B1,B1 Pro,B1 Pro Max,B1 Plus,B1 Max,B1 S,B1 SE,B1 Ultra,B1+,B1 Pro+,B1 CC
E3,E3 Pro,E3 Pro Max,E3 Plus,E3 Max,E3 S,E3 SE,E3 Ultra,E3+,E3 Pro+,E3 CC
bebird 3 E33R,bebird 3 E33R Pro,bebird 3 E33R Pro Max, bebird 3 Plus E33R ,bebird 3 E33R Max,bebird 3 E33R S
R37R,R37R Pro,R37R Pro Max,R37R Plus,R37R Max, R37R S,R37R SE,R37R Ultra,R37R+,R37R Pro+
E33R,E33R Pro,E33R Pro Max,E33R Plus,E33R Max, E33R S,E33R SE,E33R Ultra,E33R+,E33R Pro+
X7,X7 Pro,X7 Pro Max,X7 Plus,X7 Max,X7 S,X7 SE,X7 Ultra,X7+,X7 Pro+,X7 CC
bebird 3 D39R SE, bebird 3 D39R Ultra,bebird 3 D39R+,bebird 3 D39R Pro+, EarSight SE D39R,EarSight Plus D39R
Note7,Note7 Pro,Note7 Pro Max,Note7 Plus,Note7 Max,Note7 S,Note7 S
R5,R5 Pro,R5 Pro Max,R5 Plus,R5 Max,R5 S,R5 SE,R5 Ultra,R5+,R5 Pro+,R5 CC
BG01,BG01 Pro,BG01 Pro Max,BG01 Plus,BG01 Max,BG01 S,BG01 SE,BG01 Ultra,BG01+,BG01 Pro+,BG01 CC
bebird 3 E33R SE,bebird 3 E33R Ultra,bebird 3 E33R+,bebird 3 E33R Pro+,EarSight SE E33R,EarSight Plus E33R
bebird 3 I35R,bebird 3 I35R Pro,bebird 3 I35R Pro Max, bebird 3 Plus I35R ,bebird 3 I35R Max,bebird 3 I35R S
Establishment Types
Manufacture Medical Device