FDA Registration Active 🇨🇳 China

Guangzhou Berrcom Medical Device Co., Ltd

Reg #: 3008395508 · FEI: 3008395508 · Expires 2026
Products
7
Proprietary Names
18
Establishment Types
3
Classifications
7

Registration Details

Registration Name
Guangzhou Berrcom Medical Device Co., Ltd
Registration Number
3008395508
FEI Number
3008395508
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No.38 Huanzhen Xi Road, Dagang Town, Nansha
City
Guangzhou Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K130232

Owner / Operator

Firm Name
Guangzhou Berrcom Medical Device Co., Ltd
Operator Number
10032524
Address
No.38 Huanzhen Xi Road, Dagang Town, Nansha
City
Guangzhou
State
Guangdong
Postal Code
511470
Country
CN
Correspondent
Jiacheng Guo

US Agent

Business Name
Shenzhen Joyantech Consulting Co., Ltd.
Contact Name
Thomas Tang
Address
25 Hopewell Drive Stony Brook
City
Stony Brook
State
NY
ZIP
11790
Country
US
Phone
631 7511103

Products

Device Name Product Code
System, Measurement, Blood-Pressure, Non-Invasive DXN
Catheters, Suction, Tracheobronchial BSY
Clinical Electronic Thermometer SDV
Oximeter DQA
Irrigator, Powered Nasal KMA
Polymer Patient Examination Glove LZA
Oximeter, Infrared, Sporting, Aviation OCH

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 KINGFA MEDICAL, Powder Free Nitrile Examination Gloves, model: KG-1101 Berrcom, Pulse Oximeter, YM302

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility