Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008395508

FEI Number

3008395508

Entity Name

Guangzhou Berrcom Medical Device Co., Ltd

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.38 Huanzhen Xi Road, Dagang Town, Nansha, Guangzhou Guangdong 511470, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Guangzhou Berrcom Medical Device Co., Ltd (Owner Number: 10032524)

Owner / Operator Contact Address

No.38 Huanzhen Xi Road, Dagang Town, Nansha, Guangzhou, CN-GD 511470, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232989

PMA Number

N/A

All Registered Proprietary Names

Electronic Blood Pressure Monitor for Upper Arm, BPA001, BPA002 Playhouse MD Booger Buddy, Light-Up Nasal Bulb (Narwhal), Model: 1031 Playhouse MD Booger Buddy, Light-Up Nasal Aspirator (Elephant), Model: 1021, 1021-T Ear Thermometer, Model: ET101, ET102, ET103, ET106, ET107, ET108; Digital Basal Thermometer, Model: DT002, DT003, DT004, DT005, DT006; Digital Thermometer, Model: DT007, DT008, DT113, DT116, DT117, DT119; Non-contact Infrared Thermometer, Model: JXB-190, JXB-191, JXB-192, JXB-301, JXB-302, LMP001, JA001; Playhouse MD Fever Buddy, 3-in-1 Infrared Thermometer - Giraffe, Model: 1051, 1051-R Non-contact Infrared Thermometer, Model: JXB-178, JXB-182, JXB-188, JXB-195, JXB-180, JXB-181, JXB-183, JXB-186, JXB-189 Ear Thermometer, Model: ET001, MD-H30, ET003, ET005, ET008, ET009; Digital Thermometer, Model: DT101, DT102 Digital Thermometer, Model: DT001, DT007, DT008; Non-contact Infrared Thermometer, Model: JXB-311, JXB-315, JXB-319, JXB-320; Pulse Oximeter, model: AOJ-70C Nose Cleaner, NC001, NC003, NC005 Nasal aspirator, NC006, NC010, NC011, NC012, NC007, NC013, NC014, NC015 Pulse Oximeter, model: AOJ-70C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-12-17
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2025-06-23
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-05-16
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2014-05-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-22

Official Correspondent

Jiacheng Guo

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Guangzhou Berrcom Medical Device 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

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3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008395508. Last updated year: 2026. Please use registration number 3008395508 when referencing this establishment in official correspondence.