510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Guangdong Biolight Meditech Co., Ltd

Zhuhai Guangdong, CN

GUANGDONG BIOLIGHT MEDITECH CO., LTD appears in FDA device records in Zhuhai Guangdong, CN. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for Guangdong Biolight Meditech Co., Ltd between 2008 and 2019. The busiest year on record is 2016, with 5. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Guangdong Biolight Meditech Co., Ltd, by decision year
YearClearances
20081
20103
20111
20123
20131
20144
20165
20172
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K181919Patient MonitorMWISubstantially Equivalent
K170514Central Monitoring SystemMHXSubstantially Equivalent
K162234Truscope Ultra Patient MonitorMWISubstantially Equivalent
K160349Electronic SphygmomanometerDXNSubstantially Equivalent
K153580Central Monitoring SystemHGMSubstantially Equivalent
K153135VITAL SIGNS MONITORMWISubstantially Equivalent
K152739Electronic ThermometerFLLSubstantially Equivalent
K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DDQASubstantially Equivalent
K131858DIGITAL ELECTROCARDIOGRAPHDPSSubstantially Equivalent
K131762HANDHELD MONITORMWISubstantially Equivalent
K131941FETAL MONITORSHGMSubstantially Equivalent
K131898A SERIES AND Q SERIES PATIENT MONITORSMWISubstantially Equivalent
K131763TRUSCOPE SERIES PATIENT MONITORMHXSubstantially Equivalent
K120193ANY VIEW PATIENT MONITORSMWISubstantially Equivalent
K113833VITAL SIGNS MONITORMWISubstantially Equivalent
K112804FINGERTIP PULSE OXIMETERDQASubstantially Equivalent
K112803PATIENT MONITORMHXSubstantially Equivalent
K102040PATIENT MONITORMHXSubstantially Equivalent
K101694HANDHELD PULSE OXIMETER MODEL M800DQASubstantially Equivalent
K100046M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000MHXSubstantially Equivalent
K081712FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700DQASubstantially Equivalent

Registered establishments

FDA registered establishments for Guangdong Biolight Meditech Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30073056243007305624GUANGDONG BIOLIGHT MEDITECH CO., LTDNo.9 Yonghe Road, Zhuhai Guangdong 519085 CN2026and 9 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Guangdong Biolight Meditech Co., Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain