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
- [email protected]
- Phone
- 631 7511103
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-12-17 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2025-06-23 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-13 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-05-16 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2014-05-06 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-05-23 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2025-11-30 |
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