Iprovèn

Ear thermometer with bluetooth which transmits data to app on mobile phone

Registry build 21.09.26
115manufacturers in China registered for this device type
34catalogue numbers in this listing

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 iProvèn
Listed by Masena Invest B.V.
FDA product code FLL
Device type Continuous Measurement Thermometer
Device class Class 2
Regulation 21 CFR 880.2910
510(k) K131243
Record published 2016-09-23
Record revised 2022-05-23 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation High-level Disinfectant
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for iProvèn
Catalogue number Size Status
DMT-489 In distribution
BBT-271B-22395 In distribution
DT-R1221B-US-WG In distribution
DMT-316w In distribution
BBT-113Ai-US-WG In distribution
BBT-113i In distribution
BBT-113A2 In distribution
TMT-215 In distribution
DTR-1221-US-BGW In distribution
DT-K117B In distribution
DMT-316-new In distribution
DMT-489-new In distribution
BBT-113i-US-WG In distribution
BBT-113A-W In distribution
DT-K117A In distribution
DT-K117B-US-WG In distribution
DMT-489g In distribution
DT-R1221A-W In distribution
DTR-1221-US-BG In distribution
DT-R1221B In distribution
BBT-113Ai In distribution
DT-R1221A-US-WG In distribution
DMT-316b In distribution
DT-R1221A In distribution
DT-K117A-US-WG In distribution
DTR-1221-US-P In distribution
BBT-271A-22388 In distribution
DTR-1221-US-BLU In distribution
ET-624BT In distribution
DMT-489-W In distribution
DMT-316 In distribution
DMT-489-2 In distribution
DT-R1221A2 In distribution
ET-828BT In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unimed Unimed Medical Supplies Inc 434
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

Showing 12 of 843. All products under Continuous Measurement Thermometer

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