Unimed

Unimed’s disposable 2-pin temperature probe is a single-patient accessory for measuring temperature through a compatible patient monitor. The filed variant is a body-cavity probe with an 18…

Registry build 21.09.26

Unimed’s disposable 2-pin temperature probe is a single-patient accessory for measuring temperature through a compatible patient monitor. The filed variant is a body-cavity probe with an 18 Fr body and a 0.76 m lead, intended for esophageal auscultation with a stethoscope.

The probe provides the temperature-sensing interface; its connector links the sensor to the monitor. The 2-pin format and probe dimensions define the listed configuration within Unimed’s disposable temperature-probe range.

Listed Item

Disposable temperature probe/universal 2PIN/body cavity/18Fr/0.76M (auscultation of the esophagus/with stethoscope)

Probe Connection

Unimed lists probes by measurement site and monitor connector. This item is the esophageal, two-pin disposable configuration identified in the filed model.

115manufacturers in China registered for this device type
434catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FLL
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Zhejiang Hongyu Medical Commodity Co., Ltd. Yiwu Zhejiang Contract manufacturer 36
Hochuen Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Famidoc Technology Co., Ltd. Dong Guan Guangdong Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Tasco Medical Industries Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 6
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Betacera Inc. Suzhou Jiangsu Contract manufacturer 3

Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer

Record

Regulatory record for Unimed
Listed by Unimed Medical Supplies Inc, China
FDA product code FLL
Device type Continuous Measurement Thermometer
Device class Class 2
Regulation 21 CFR 880.2910
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter
Record published 2022-04-01
Record revised 2024-10-28 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Carton box of 20, carton box of 10, carton box, box of 20, 16945664857274 of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Unimed
Catalogue number Size Per pack Status
T35-PS In distribution
AU1004 In distribution
NCMQ5204 In distribution
G-TWMR-PR In distribution
T700-AS In distribution
TBLT-AG In distribution
TAS30-D-10-N In distribution
TDGD-15PS In distribution
TDT-AS In distribution
TDT-AG In distribution
UFU600-100 In distribution
TSM16-DAG-10 In distribution
TCTSM-15AS In distribution
THP-D In distribution
DAS-PS0 In distribution
590004(TEMP-R) In distribution
TDVD-15PS In distribution
ATP19-FP-561 In distribution
TWTL-AS In distribution
TDRE-AG In distribution
ASM21090AE In distribution
DSL-AS0 In distribution
TMQ-AE In distribution
TBNT-AG In distribution
T10-PS In distribution
NCPH5301-6 In distribution
INF-400T0R In distribution
T2252-PG In distribution
G-TEDR-AR-15 In distribution
T2252-AS In distribution
TMQ-PG In distribution
DDG30-D-200 In distribution
T3M510-17PS In distribution
TAMT-15PG In distribution
TBNT-PS In distribution
TOMP-GE-001 In distribution
TAT30-D-20-N In distribution
ASD-TMQ In distribution
TMQ-DAG In distribution
TDGA-PS In distribution
TP22-RD-002 In distribution
NCAS5172 In distribution
TOMH-17PS In distribution
PTMR-AG In distribution
TEDA-AG In distribution
TBNT-AS In distribution
TMQ-AG In distribution
NCPH5301 In distribution
TMQ-DG-20 In distribution
09059 In distribution
TDG15-DPS In distribution
MS-EDANTOCO6D In distribution
DAT-15PS0 In distribution
T2252M-PG In distribution
TOP-WA-003XL In distribution
DMQ-AS0 In distribution
T3510-AS In distribution
TRP-AR-001 In distribution
T2252S-AS In distribution
NCYS5176-6 In distribution
DMQ-DAG-20-N0 In distribution
TP22-BL-002 In distribution
TRP-WA-002L In distribution
DBLT-AS0 In distribution
TAS30-D-20-N In distribution
D2252-AS0 In distribution
09058 In distribution
DRP-GE-0010 In distribution
T2P9ST-DG In distribution
UFU200-10 In distribution
TDVA-PS In distribution
T3M510-D-10 In distribution
THP-D-N In distribution
NCYS5101-7 In distribution
TLTPB-002-004 In distribution
DHP-AS0 In distribution
NCDRE5101 In distribution
TCMB-AG In distribution
TP22-BL-003 In distribution
ASN401HP-U In distribution
TSL2-AS(TOH-PS) In distribution
D700-AG0 In distribution
T20-15PS In distribution
DHP45-AS0 In distribution
TC-02893-000 In distribution
T3510/30-D In distribution
TMMR-PS In distribution
TRP-MR-001 In distribution
NCSD5101 In distribution
DAS30-D-200 In distribution
NCAL5610 In distribution
THP-DAG-N In distribution
TSM-15AS In distribution
NCPH5171 In distribution
P05246 In distribution
TSM16-D-10 In distribution
NCFP5201 In distribution
TSL-AG In distribution
TDG-D-N In distribution
TSM-AG In distribution
NFPH8911 In distribution
AU1006 In distribution
TFP-AS In distribution
NCMR5101 In distribution
02893-000 In distribution
TMQ-D-20-N In distribution
DT582 In distribution
TRMP-GE-001 In distribution
TOP-WA-002L/B In distribution
TMR-AS In distribution
THP-AG In distribution
TAT-15PG In distribution
T10-AG In distribution
SIBIM-THP-AS In distribution
D3510-PS0 In distribution
TAT30-D-10-N In distribution
NCSP5204 In distribution
TAT30-D-N In distribution
TOH30-D-N In distribution
DHP-DAS0 In distribution
STWD30-MRS In distribution
8032009(U) In distribution
LML-THP12W-DG-20 In distribution
8032009 In distribution
USOC7393 In distribution
TP22-BL-001 In distribution
X-US-CR20 In distribution
TOP-MR-001 In distribution
USOC5500 In distribution
T2P18ST-DG In distribution
T2252-AS(T2252-PS) In distribution
YSI-402 In distribution
TSIE-15AS In distribution
USOC7741 In distribution
T2P12W-DG-20 In distribution
THP-D-20-N In distribution
NCYS5102-6 In distribution
MS-EDANFP10US In distribution
NCYS5101-6 In distribution
TDRE-AS In distribution
T3510-17PS In distribution
TDG-DAG In distribution
TMR-AG In distribution
TAMS30-D-10 In distribution
TMQ-PS In distribution
DHP-D-20-N0 In distribution
T2P9W-DG In distribution
SI2264 In distribution
TMR-PS In distribution
09054 In distribution
C318-0008 In distribution
TAS-PS In distribution
TDVA-15PS In distribution
TCMB-PS In distribution
TP22-RD-001 In distribution
TMR-DAG-20 In distribution
TAMT-PG In distribution
TEDB-AS In distribution
PTMQ-DAG In distribution
MT10-AS In distribution
AT1003 In distribution
10160 In distribution
NCFP5101 In distribution
TYSI30-DAG In distribution
D2252-PG0 In distribution
DMQ2-AS0 In distribution
C415-0023 In distribution
TYSI30-DAG-10 10 In distribution
THMP-DAG-20 In distribution
TDVB-15PS In distribution
CTDVC-15PS In distribution
DMQ-DAS0 In distribution
DOH-PS0 In distribution
TOH-17PS In distribution
10115 In distribution
USOC0001 In distribution
T3510/30-D-20-N In distribution
ATP09-FP-805 In distribution
TSM-AS In distribution
TDG-D-10-N In distribution
TMR-AS In distribution
AT1002 In distribution
TTR-PS In distribution
YSI-401 In distribution
TDGA10-DPS In distribution
TSM30-D-10 In distribution
DAS-15PS0 In distribution
TDT-PG In distribution
D3510-D-200 In distribution
TOP-WA-003 In distribution
TSM-PS In distribution
TMQ-DAG-20 20 In distribution
CAB-74001-TE In distribution
AT2003 In distribution
LML-THP9W-DG-20 In distribution
AT2004 In distribution
T63SB-AS In distribution
USOC0003 In distribution
DDT-PG0 In distribution
SI5700 In distribution
TDG-D-20-N In distribution
10084 In distribution
ATP04-FP-806 In distribution
PTMR-AS In distribution
T700-PS In distribution
TMQ-AS/AG In distribution
DDRE-AG0 In distribution
ETU2252-AS In distribution
USOCI401 In distribution
DMQ-AG0 In distribution
TBNT-15PS In distribution
FFCM3260 In distribution
TMQ-AS In distribution
THP-AS In distribution
TEM.SEN.03 In distribution
TEDA-AS In distribution
T3510-D-20 In distribution
T2M252-AS In distribution
T20-155AS In distribution
AT1004 In distribution
U533-01 In distribution
TOMP-AR-002 In distribution
USOC5700 In distribution
TEM.SEN.02 In distribution
USOC7382 In distribution
TMQ-D In distribution
PTHP-AG In distribution
T2252S-PG In distribution
TEM.SEN.01 In distribution
DT581 In distribution
TCMB-PG In distribution
ATP21-FP-869 In distribution
TMR30-D-10 In distribution
T700-AG In distribution
FFCM3205 In distribution
ATMP21-FP-869 In distribution
NCDA5172 In distribution
TRP-AR-002 In distribution
PTHP-AS In distribution
TDGD-15PS In distribution
10554 In distribution
10085 In distribution
DOP-MR-0010 In distribution
MDR-0206-03-0212-02 In distribution
DMR-PG0 In distribution
NCAS5101 In distribution
TSML-AS In distribution
T2252-AG In distribution
TDGD-PS In distribution
10092 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Safety 1st Dorel Juvenile Group, Inc. 180
Welch Allyn, Inc. Welch Allyn, Inc. 66
Diagnostix™ American Diagnostic Corp. 61
DeRoyal Deroyal Industries, Inc. 58
Braun KAZ USA, Inc. 53
Exergen Temporal Scanner Exergen Corporation 50
Level 1 ICU Medical, Inc 48
Famidoc Famidoc Technology Co., Ltd. 47
Adtemp™ American Diagnostic Corp. 35
TempTraq Blue Spark Technologies, Inc. 35
Medline Medline Industries, Inc. 34
Mabis D-M-S Holdings, Inc. 34

Showing 12 of 843. All products under Continuous Measurement Thermometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K253162 2026-06-05
K121427 2012-05-29

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer