Unimed
The FDA filing identifies Unimed disposable and reusable SpO2 sensors and lists models including U103-01, U403-01, U543-01, and N543-01. The summary describes sensors with two…
The FDA filing identifies Unimed disposable and reusable SpO2 sensors and lists models including U103-01, U403-01, U543-01, and N543-01.
The summary describes sensors with two specific-wavelength LEDs and a photodetector assembled in the sensor housing, designed to function with a compatible OEM pulse-oximeter sensor.
Listed Item
CAPTEUR SPO2 PATIENT UNIQUE NEONATAL < 3 kg et ADULT > 40 kg COMPATIBLE TRUSIGNAL L :0.9M SINGLE PATIENT SPO2 SENSOR NEONATAL < 3 kg and ADULT > 40 kg TRUSIGNAL COMPATIBLE L :0.9M
Device Description and Stated Use
The stated use is continuous, noninvasive monitoring of functional arterial hemoglobin oxygen saturation and pulse rate for adult, pediatric, and neonatal patients within the listed weight groups.
70manufacturers in China registered for this device type
2,838catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Unimed Medical Supplies Inc, China |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K142832 |
| Record published | 2022-03-25 |
| Record revised | 2024-10-28 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Carton box of 24, box of 24, 16945664825105 of 24, carton of 24, 16945664826034 of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCPF-0510-0321 | In distribution | |
| DTG-NLCR-N | In distribution | |
| S503-490 | In distribution | |
| U910-29 | In distribution | |
| U603-08 | In distribution | |
| NHNK5725-TA | In distribution | |
| NHPH1025 | In distribution | |
| F533-01XP | In distribution | |
| U410-75N | In distribution | |
| PU410-137 | In distribution | |
| U410-223 | In distribution | |
| P10-09M | In distribution | |
| CL2301 | In distribution | |
| E503-01P | In distribution | |
| F523-125 | In distribution | |
| S803-49V0 | In distribution | |
| NHMR3070 | In distribution | |
| U803-125 | In distribution | |
| U810-16 | In distribution | |
| U410-08T | In distribution | |
| U310-195P | In distribution | |
| U410-29.ED | In distribution | |
| U1M10-36 | In distribution | |
| U410S-206 | In distribution | |
| U310-205D | In distribution | |
| U503-125R | In distribution | |
| NSMQ3045 | In distribution | |
| U603-49 | In distribution | |
| P04-30M | In distribution | |
| U4M10S-91 | In distribution | |
| U403-254R | In distribution | |
| U210S-20 | In distribution | |
| U803-42D | In distribution | |
| S403-150 | In distribution | |
| U803-49 | In distribution | |
| S543-160 | In distribution | |
| U310-66D | In distribution | |
| U410E-37 | In distribution | |
| U5M43-09 | In distribution | |
| U110-175 | In distribution | |
| U110S-01 | In distribution | |
| U110S-147 | In distribution | |
| P503-01 | In distribution | |
| TCPS-1206-0212 | In distribution | |
| U410S-70P | In distribution | |
| U810-87 | In distribution | |
| U410-108 | In distribution | |
| U411-15 | In distribution | |
| U910-21 | In distribution | |
| U403-73 | In distribution | |
| U903-01P | In distribution | |
| IBM810-46D | In distribution | |
| TL122113A110-CA99 | In distribution | |
| PU543-26 | In distribution | |
| U410-56 | In distribution | |
| U410S-10 | In distribution | |
| TC310-65D | In distribution | |
| S543-1170 | In distribution | |
| U210S-15 | In distribution | |
| U410-254 | In distribution | |
| U410-159D | In distribution | |
| PU410-91M | In distribution | |
| NXDX5080 | In distribution | |
| TL122113A300-CU | In distribution | |
| U110S-16L | In distribution | |
| P06809 | In distribution | |
| U410S-07 (RU4)* | In distribution | |
| U410-91M | In distribution | |
| NSBC1825 | In distribution | |
| 2210 | In distribution | |
| TC310-36 | In distribution | |
| U103S-09 | In distribution | |
| E403-02 | In distribution | |
| U310-180P | In distribution | |
| CL6304 | In distribution | |
| S533-070 | In distribution | |
| M150-01LP | In distribution | |
| U4M10-02 | In distribution | |
| PU110-46D | In distribution | |
| 90720UNS | In distribution | |
| U410-45 | In distribution | |
| U810-84D | In distribution | |
| U523-01XP | In distribution | |
| S410S-21P0 | In distribution | |
| U903-62D | In distribution | |
| PU110S-311 | In distribution | |
| U203S-125 | In distribution | |
| SIBIM410-01 | In distribution | |
| S523-090 | In distribution | |
| NSNN1725 | In distribution | |
| F523-117 | In distribution | |
| U903-09 | In distribution | |
| U310-65D | In distribution | |
| N5M43-01 | In distribution | |
| MCU2003S049 | In distribution | |
| U403-29 | In distribution | |
| P02T-11M | In distribution | |
| U110-46D | In distribution | |
| U523-42D | In distribution | |
| U410S-03 | In distribution | |
| FCU403S-91 | In distribution | |
| U310-69 | In distribution | |
| U903-125 | In distribution | |
| USOC651T3 | In distribution | |
| NSNE3003-OM | In distribution | |
| U203S-125R | In distribution | |
| R403-01X | In distribution | |
| NHNE5026-FA | In distribution | |
| U305-91 | In distribution | |
| S403-62D0 | In distribution | |
| U533-01.ED | In distribution | |
| AS1016 | In distribution | |
| U410-18 | In distribution | |
| PU410-108 | In distribution | |
| MCU303006 | In distribution | |
| U5M23-09 | In distribution | |
| NSDX3050 | In distribution | |
| PU910-21MR | In distribution | |
| AS505E-U | In distribution | |
| U410-31 | In distribution | |
| NHDX5680-TA | In distribution | |
| NYNE3125 | In distribution | |
| AC-AC-111-3 | In distribution | |
| S810-290 | In distribution | |
| U543-49 | In distribution | |
| SB-NCRO-3A | In distribution | |
| U803-203R(CSM) | In distribution | |
| U103-49R(CSM) | In distribution | |
| U523-49R | In distribution | |
| U411-121 | In distribution | |
| UVC-02 | In distribution | |
| S503-1250 | In distribution | |
| U410-32 | In distribution | |
| NSPH2020 | In distribution | |
| U605-16 | In distribution | |
| GS DW-05TS/AN | In distribution | |
| U203S-01P | In distribution | |
| U103-49 | In distribution | |
| S533-060 | In distribution | |
| U110S-208 | In distribution | |
| U410S-69 | In distribution | |
| AC-PS-111-3 | In distribution | |
| U410B-208 | In distribution | |
| U303-49R | In distribution | |
| NSKM0030 | In distribution | |
| NYMA1127 | In distribution | |
| U403S-42D | In distribution | |
| U603-08T | In distribution | |
| U403-01(GMI) | In distribution | |
| U110S-03 | In distribution | |
| U403-49(Partssource) | In distribution | |
| U810-07 | In distribution | |
| GS SI-1091N | In distribution | |
| R410-29 | In distribution | |
| NHKM0030 | In distribution | |
| S110S-910 | In distribution | |
| U410B-37 | In distribution | |
| C415-0095 | In distribution | |
| U503-16L | In distribution | |
| R410-09 | In distribution | |
| U903-49 | In distribution | |
| U5M23-49 | In distribution | |
| G-TWMR-PS | In distribution | |
| U910-08L | In distribution | |
| U310-61D | In distribution | |
| TCPF-1206-0212 | In distribution | |
| NYMQ3146 | In distribution | |
| SWBD30-91 | In distribution | |
| U410B-66D | In distribution | |
| AS500EGEL | In distribution | |
| U403S-125R(CSM) | In distribution | |
| NHNE5626-NA | In distribution | |
| U310-58 (RU2)* | In distribution | |
| E533-01P | In distribution | |
| CL8301 | In distribution | |
| E403-01P | In distribution | |
| OXM.SEN.09 | In distribution | |
| U810-62D | In distribution | |
| N543-49R | In distribution | |
| U543-42D | In distribution | |
| IBM810-113 | In distribution | |
| 10274 | In distribution | |
| CF523-01 | In distribution | |
| F533-05 | In distribution | |
| TL122113EXT110-CA45 | In distribution | |
| S410S-46D0 | In distribution | |
| U403S-07 | In distribution | |
| U110S-30M | In distribution | |
| CL10101 | In distribution | |
| GS DW-91/PI | In distribution | |
| U110-74 | In distribution | |
| AC-AC-113-3 | In distribution | |
| U103-125R | In distribution | |
| U305-08L | In distribution | |
| N5XX-07 (RU7)* | In distribution | |
| U310-06 | In distribution | |
| S110S-690 | In distribution | |
| DP063X-09M | In distribution | |
| U543-01 (RU)* | In distribution | |
| PU403S-91 | In distribution | |
| F503V-01P | In distribution | |
| U110S-91 | In distribution | |
| U910-48P | In distribution | |
| U810-75 | In distribution | |
| U803-91 | In distribution | |
| U543-26 | In distribution | |
| SIBIM410-21 | In distribution | |
| U310-09 | In distribution | |
| U310-208D | In distribution | |
| U410-152M | In distribution | |
| C415-0028 | In distribution | |
| F543/30-91M | In distribution | |
| U103-01XP | In distribution | |
| U110-29 | In distribution | |
| E543-01XP | In distribution | |
| P12S-11M | In distribution | |
| U103S-03 | In distribution | |
| U110-147 | In distribution | |
| S543-060 | In distribution | |
| 94720ME | In distribution | |
| U410-21P | In distribution | |
| USOCLNOPTCM | In distribution | |
| NHDX5665-TA | In distribution | |
| NYSN3090 | In distribution | |
| C415-0019 | In distribution | |
| U410B-15 | In distribution | |
| S403S-2030 | In distribution | |
| S4U03-01 | In distribution | |
| U403B-127 | In distribution | |
| U401-307 | In distribution | |
| NSPH1020 | In distribution | |
| U803-16 | In distribution | |
| U410S-01P | In distribution | |
| U110-21 | In distribution | |
| S533-2030 | In distribution | |
| TCPF-2118-0112 | In distribution | |
| UC-60E | In distribution | |
| U410-48 | In distribution | |
| U410S-50D | In distribution | |
| U910-152M | In distribution | |
| NYNE3003-OM | In distribution | |
| U403B-06 | In distribution | |
| PU410S-01P | In distribution | |
| U410B-96 | In distribution | |
| U103-01P | In distribution | |
| CF523-01XP | In distribution | |
| NHDX5725-FA | In distribution | |
| U4M03S-49 | In distribution | |
| NSPH3720 | In distribution | |
| N543-125R | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
| AMC | LifeSync Corporation | 36 |
Showing 12 of 1,063. All products under Oximeter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260931 | 2026-04-14 |
| K251696 | 2025-12-01 |
| K251691 | 2025-12-01 |
| K251693 | 2025-11-18 |
| K251695 | 2025-11-18 |
| K250931 | 2025-08-13 |
| K243086 | 2025-02-20 |
| K242580 | 2025-02-06 |
| K222213 | 2022-12-19 |
| K142832 | 2015-02-06 |
| K082546 | 2008-12-02 |
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.