HEIFENG ZHIZAO(SHENZHEN)TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · shenzhen Guangdong, CN · Registration 3016170496

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016170496
FEI Number
3016170496
Entity Name
HEIFENG ZHIZAO(SHENZHEN)TECHNOLOGY CO.,LTD
City/State/Country
shenzhen Guangdong, CN
Establishment Address
Room 1205, Building 1, Vanke Xingchen Building, Xinqiao Street, Bao an District, shenzhen Guangdong 518000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Heifeng Zhizao(Shenzhen)Technology Co.,Ltd (Owner Number: 10061660)
Owner / Operator Contact Address
Floor 1, Building 6, Gangzai Street, Furong Industrial Zone, Xiangshan Community,, Xinqiao Street, Bao an District, shenzhen, CN-GD 518000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OTOSCOPE (W3,W3 Pro,W3 Pro Max,W3 Plus,W3 Max,W3 S,W3 SE,W3Ultra,W3+,W3 Pro+,W3 CC) OTOSCOPE (D3,D3 Pro,D3 Pro Max,D3 Plus,D3 Max,D3 S,D3 SE,D3 Ultra,D3+,D3 Pro+,D3 CC) OTOSCOPE (bebird 3 B31R,bebird 3 B31R Pro,bebird 3 B31R Pro Max,bebird 3 Plus B31R ,bebird 3 B31R Max,bebird 3) OTOSCOPE(Earcare 3 Plus,Earcare 3 Plus+,Earcare 3 Se,Earcare 3 +, Earcare 3,E Care 3 Ultra,E Care 3 Ultra X,E Care 3Pro) OTOSCOPE (K3, K3 Pro, K3 Pro Max, K3 Plus, K3 Max, K3 S, K3 SE, K3 Ultra, K3+, K3 Pro+) OTOSCOPE (Note3,Note3 Pro,Note3 Pro Max,Note3 Plus,Note3 Max,Note3 S,Note3 SE,Note3 Ultra,Note3+,Note3 Pro+,Note3 CC) OTOSCOPE (Care 3 Ultra,Care 3 Ultra X,Care 3 Pro ,Care 3 Pro Max,Care 3 Max,Care 3 Air,Care 3 Plus,Care 3 Plus+) OTOSCOPE (bebird 3 R37R SE,bebird 3 R37R Ultra,bebird 3 R37R+,bebird 3 R37R Pro+, EarSight SE R37R,EarSight Plus R37R) OTOSCOPE (B31R S,bebird 3 B31R SE,bebird 3 B31R Ultra) OTOSCOPE (I35R,I35R Pro,I35R Pro Max,I35R Plus,I35R Max,I35R S ,I35R SE,I35R Ultra,I35R+,I35R Pro+,bebird 3 I35R) OTOSCOPE (Earsight Ultra,Earsight Ultra X,Earsight Pro,Earsight Pro Max,Earsight Max,Earsight Air,Earsight Plus) OTOSCOPE (E3,E3 Pro,E3 Pro Max,E3 Plus,E3 Max,E3 S,E3 SE,E3 Ultra,E3+,E3 Pro+,E3 CC) OTOSCOPE (Q3,Q3 Pro,Q3 Pro Max,Q3 Plus,Q3 Max,Q3 S,Q3 SE) OTOSCOPE (B31R,B31R Pro,B31R Pro Max,B31R Plus,B31R Max, B31R S,B31R SE,B31R Ultra,B31R+,B31R Pro+) OTOSCOPE (bebird 3 I35R SE,bebird 3 I35R Ultra,bebird 3 I35R+,bebird 3 I35R Pro+, EarSight SE I35R,EarSight Plus I35R) OTOSCOPE (bebird 3 I35R Pro,bebird 3 I35R Pro Max,bebird 3 Plus I35R ,bebird 3 I35R Max,bebird 3 I35R S) OTOSCOPE (Home 30 Pro Max, Home 30 Plus, Home 30 Ultral, Home 30 SE, Home 30 Mini, Home 30 Power) OTOSCOPE (R37R,R37R Pro,R37R Pro Max,R37R Plus,R37R Max,R37R S,R37R SE,R37R Ultra,R37R+,R37R Pro+,bebird 3 R37R) OTOSCOPE (Earsight Se Care 3 Se,Care 3 +,Care 3,Earcare 3 Ultra,Earcare 3 Ultra X,Earcare 3 Pro,Earcare 3 Pro Max) OTOSCOPE (E33R,E33R Pro,E33R Pro Max,E33R Plus,E33R Max, E33R S,E33R SE,E33R Ultra,E33R+,E33R Pro+,bebird 3 E33R) OTOSCOPE (Note7,Note7 Pro,Note7 Pro Max,Note7 Plus,Note7 Max,Note7 S,Note7 SE) OTOSCOPE (bebird 3 D39R SE,bebird 3 D39R Ultra,bebird 3 D39R+,bebird 3 D39R Pro+, EarSight SE D39R,EarSight Plus D39R) OTOSCOPE (R1,R1 Pro,R1 Pro Max,R1 Plus,R1 Max,R1 S,R1 SE,R1 Ultra,R1+,R1 Pro+,R1 CC) OTOSCOPE (E Care 3 Pro Max,E Care 3 Max,E Care 3 Air,E Care 3 Plus, E Care 3 Plus+,E Care 3 Se,E Care 3 +,E Care 3) OTOSCOPE (X7,X7 Pro,X7 Pro Max,X7 Plus,X7 Max,X7 S,X7 SE,X7 Ultra,X7+,X7 Pro+,X7 CC) OTOSCOPE (R3,R3 Pro,R3 Pro Max,R3 Plus,R3 Max,R3 S,R3 SE,R3 Ultra,R3+,R3 Pro+,R3 CC) OTOSCOPE (T15,T15 Pro,T15 Pro Max,T15 Plus,T15 Max,T15 S,T15 SE,T15Ultra,T15+,T15 Pro+,T15 CC) OTOSCOPE (Home 30 Turbo, Home 30 Eco, Home 30 All, Home 7, Home 7 Max, Home 7 Ultra, Home 7 Plus, Home 7X) OTOSCOPE (D39R,D39R Pro,D39R Pro Max,D39R Plus,D39R Max, D39R S,D39R SE,D39R Ultra,D39R+,D39R Pro+,bebird 3 D39R) OTOSCOPE (Earcare 3 Max,Earcare 3 Air Pure 10,Elite 14,Elite 14W,Max 22,Elite 14W/Elite 14 Earsight +,Earsight) OTOSCOPE (R5,R5 Pro,R5 Pro Max,R5 Plus,R5 Max,R5 S,R5 SE,R5Ultra,R5+,R5 Pro+,R5 CC) OTOSCOPE (X0,X0 Pro,X0 Pro Max,X0 Plus,X0 Max,X0 S,X0 SE, K10,K10 Pro,K10 Pro Max,K10 Plus,K10 Max,K10 S,K10 S) OTOSCOPE (B1,B1 Pro,B1 Pro Max,B1 Plus,B1 Max,B1 S,B1 SE,B1Ultra,B1+,B1 Pro+,B1 CC) OTOSCOPE (X1,X1 Pro,X1 Pro Max,X1 Plus,X1 Max,X1 S,X1 SE,X1 Ultra,X1+,X1 Pro+,X1 CC) OTOSCOPE (Home 30, Home 30X, Home 30S, Home 30E, Home 30C, Home 30H, Home 30P, Home 30 Pro, Home 30 Max) OTOSCOPE (bebird 3 E33R Pro,bebird 3 E33R Pro Max, bebird 3 Plus E33R ,bebird 3 E33R Max,bebird 3 E33R S) OTOSCOPE (BG01,BG01 Pro,BG01 Pro Max,BG01 Plus,BG01 Max,BG01 S,BG01 SE,BG01 Ultra,BG01+,BG01 Pro+,BG01 CC) OTOSCOPE (C3,C3 Pro,C3 Pro Max,C3 Plus,C3 Max,C3 S,C3 SE,C3Ultra,C3+,C3 Pro+,C3 CC) OTOSCOPE (T3 Pro, T3 Pro Max, T3 Plus, T3 Max, T3 S, T3 SE, T3 Ultra,T3+, T3Pro+) OTOSCOPE (B2,B2 Pro,B2 Pro Max,B2 Plus,B2 Max,B2 S,B2 SE,B2 Ultra,B2+,B2 Pro+,B2 CC) OTOSCOPE (Note5,Note5 Pro,Note5 Pro Max,Note5 Plus,Note5 Max,Note5 S,Note5 SE) OTOSCOPE (bebird 3 R37R Pro,bebird 3 R37R Pro Max,bebird 3 Plus R37R ,bebird 3 R37R Max,bebird 3 R37R S) OTOSCOPE (bebird 3 B31R+,bebird 3 B31R Pro+,EarSight SE B31R,EarSight Plus B31R) OTOSCOPE (M9,M9 Pro,M9 Pro Max,M9 Plus,M9 Max,M9 S,M9 SE,M9 Ultra,M9+,M9 Pro+,M9 CC) OTOSCOPE (P30,P30 Pro,P30 Pro Max,P30 Plus,P30 Max,P30 S,P30 SE,P30 Ultra,P30+,P30 Pro+,P30 CC) OTOSCOPE (A2,A2 Pro,A2 Pro Max,A2 Plus,A2 Max,A2 S,A2 SE,A2Ultra,A2+,A2 Pro+,A2 CC) OTOSCOPE (T5,T5 Pro,T5 Pro Max,T5 Plus,T5 Max,T5 S,T5 SE,T5 Ultra,T5+,T5 Pro+,T5 CC) OTOSCOPE (bebird 3 D39R Pro,bebird 3 D39R Pro Max,bebird 3 Plus D39R ,bebird 3 D39R Max,bebird 3 D39R S) OTOSCOPE (Home 7S, Home 7E, Home 7 SE, Home 7C) OTOSCOPE (X17,X17 Pro,X17 Pro Max,X17 Plus,X17 Max,X17 S,X17 SE,X17 Ultra,X17+,X17 Pro+,X17 CC) OTOSCOPE (bebird 3 E33R SE,bebird 3 E33R Ultra,bebird 3 E33R+,bebird 3 E33R Pro+,EarSight SE E33R, EarSight Plus E33R) OTOSCOPE (X3,X3 Pro,X3 Pro Max,X3 Plus,X3 Max,X3 S,X3 SE,X3 Ultra,X3+,X3 Pro+,X3 CC) Brush, dermabrasion, powered PICK, MICROSURGICAL EAR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2019-11-06
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2022-01-13
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2024-12-12

Official Correspondent

quan lai lv

US Agent Details

Johannes Wilson Business: REP America LLC Email: info@rep-america.net Phone: (719) 2013314

Related Public Records

Same Entity

Heifeng Zhizao(Shenzhen)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
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016170496. Last updated year: 2026. Please use registration number 3016170496 when referencing this establishment in official correspondence.
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