510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Unimed Medical Supplies Inc

Shenzhen Guangdong, CN

UNIMED MEDICAL SUPPLIES INC appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 20 510(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
20
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 20 510(k) clearances for Unimed Medical Supplies Inc between 2008 and 2026. The busiest year on record is 2025, with 8. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Unimed Medical Supplies Inc, by decision year
YearClearances
20082
20111
20122
20141
20151
20211
20221
20258
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)FLLSubstantially Equivalent
K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQASubstantially Equivalent
K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQSubstantially Equivalent
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)DQASubstantially Equivalent
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)DQASubstantially Equivalent
K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)DQASubstantially Equivalent
K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)DQASubstantially Equivalent
K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)DQASubstantially Equivalent
K251045Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)DXQSubstantially Equivalent
K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)DQASubstantially Equivalent
K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)DQASubstantially Equivalent
K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)DQASubstantially Equivalent
K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+CCKSubstantially Equivalent
K142832Unimed Disposable and Reusable SPO2 SensorsDQASubstantially Equivalent
K142489Unimed Disposable ECG lead wiresDSASubstantially Equivalent
K121427UNIMED TEMPERATURE PROBEFLLSubstantially Equivalent
K120364UNIMED DISPOSABLE BLOOD PRESSURE CUFFDXQSubstantially Equivalent
K112544UNIMED BLOOD PRESSURE CUFFDXQSubstantially Equivalent
K082546REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)DQASubstantially Equivalent
K082959PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORSDSASubstantially Equivalent

Registered establishments

FDA registered establishments for Unimed Medical Supplies Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30073074873007307487UNIMED MEDICAL SUPPLIES INCBld #8,Nangang 3rd Industrial park, tangtou, shiyan, Baoan, Shenzhen Guangdong 518108 CN2026and 5 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.

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