Guangzhou Berrcom Medical Device Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 7 device types, 51 products catalogued, 6 clearances.
Guangzhou Berrcom Medical Device Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Oximeter, Irrigator, Powered Nasal and 5 other device types. 51 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
7device types registered with the FDA
51products catalogued under its own name
6510(k) clearances
Registration
| Registered name | Guangzhou Berrcom Medical Device Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008395508 |
| FEI number | 3008395508 |
| DUNS | 529391821 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广州市倍尔康医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440115718185809W |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No.38 Huanzhen Xi Road, Dagang Town, Nansha |
| Postal code | 511470 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | Class 1 | Playhouse MD Booger Buddy, Light-Up Nasal Bulb (Narwhal), Model: 1031, Playhouse MD Booger Buddy, Light-Up Nasal Aspirator (Elephant), Model: 1021, 1021-T | 2025 | 93 |
| Clinical Electronic Thermometer | Class 2 | Ear Thermometer, Model: ET101, ET102, ET103, ET106, ET107, ET108;, Ear Thermometer, Model: ET001, MD-H30, ET003, ET005, ET008, ET009;, Playhouse MD Fever Buddy, 3-in-1 Infrared Thermometer – Giraffe, Model: 1051, 1051-R, Digital Thermometer, Model: DT001, DT007, DT008;, Non-contact Infrared Thermometer, Model: JXB-190, JXB-191, JXB-192, JXB-301, JXB-302, LMP001, JA001;, Digital Thermometer, Model: DT101, DT102 and 4 more | 2025 | 49 |
| Irrigator, Powered Nasal | Class 1 | Nose Cleaner, NC001, NC003, NC005, Nasal aspirator, NC006, NC010, NC011, NC012, NC007, NC013, NC014, NC015 | 2014 | 63 |
| Oximeter | Class 2 | Pulse Oximeter, model: AOJ-70C | 2023 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | Berrcom, Pulse Oximeter, YM302 | 2025 | 29 |
| Polymer Patient Examination Glove | Class 1 | KINGFA MEDICAL, Powder Free Nitrile Examination Gloves, model: KG-1101 | 2021 | 83 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Electronic Blood Pressure Monitor for Upper Arm, BPA001, BPA002 | 2013 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Berrcom | FLL | 25 |
| Rycom | FLL | 9 |
| Berrcom | SDV | 8 |
| Ampmed | FLL | 6 |
| Preve | FLL | 4 |
| Jonterking | FLL | 4 |
| Snomd | FLL | 4 |
| Wevapers | FLL | 3 |
| Dedeks | SDV | 3 |
| Hylogy | FLL | 3 |
| Lifechek | FLL | 3 |
| Berrcom | KMA | 3 |
| Snomd | SDV | 3 |
| Homewell Essentials | FLL | 3 |
| CocoBear | FLL | 2 |
| Elcare | FLL | 2 |
| vaxxen | FLL | 2 |
| Eco4us | FLL | 2 |
| Olangda | SDV | 2 |
| Bbluv | FLL | 2 |
| BP | SDV | 2 |
| Utopia | FLL | 2 |
| DormDoc | SDV | 1 |
| IE homewell Essentials | FLL | 1 |
| Veritas Accutemp | FLL | 1 |
| Accutemp | FLL | 1 |
| Anchu | FLL | 1 |
| Medassure | FLL | 1 |
| Linktemp | FLL | 1 |
| kidz&bellz | FLL | 1 |
| Baby Cove | KMA | 1 |
| Intey | KMA | 1 |
| Berrcom | KAM | 1 |
| Berrcom | DQA | 1 |
| Proactive | FLL | 1 |
| Alertcare | SDV | 1 |
| Kaiser Permanente | FLL | 1 |
| Tezl | FLL | 1 |
| Health Smart | KMA | 1 |
| Liaboe | FLL | 1 |
| Sprucely | FLL | 1 |
| Swingmed | KMA | 1 |
| BP | FLL | 1 |
| Rycom | SDV | 1 |
| Accumed | FLL | 1 |
| Cocobear | SDV | 1 |
| Equinox International | FLL | 1 |
| Ever+one | SDV | 1 |
| Rightcare | FLL | 1 |
| ECO-IRPro | FLL | 1 |
| Equinox | FLL | 1 |
Clearances
6 clearances name Guangzhou Berrcom Medical Device Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K214077 | 2023-01-20 | FLL | Traditional | This company |
| K213746 | 2022-04-05 | FLL | Traditional | This company |
| K213084 | 2022-02-25 | FLL | Traditional | This company |
| K213079 | 2022-02-18 | FLL | Traditional | This company |
| K213082 | 2022-01-28 | FLL | Traditional | This company |
| K191570 | 2019-11-13 | FLL | Traditional | This company |
| K232989 | 2024-07-01 | DQA | Traditional | Shenzhen AOJ Medical Technology Co., Ltd. |
| K203593 | 2021-03-19 | LZA | Traditional | Guangdong Kingfa Medical SCI.&Tech. Co., Ltd. |
| K202173 | 2020-12-07 | DQA | Traditional | Shenzhen AOJ Medical Technology Co., Ltd. |
| K130232 | 2013-09-17 | DXN | Abbreviated | Jinxinbao Electronic Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | Clinical digital thermometer, Ear thermometer, Non-contact IR thermometer, Nasal aspirator |
| Certifications | ISO 13485, MDSAP, BSCI, WCA, CE, FDA |
| Export markets | 80+ countries and areas |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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