S-Monovette®

S-Monovette® 7.5ml LH for trace metals

Registry build 21.09.26
23manufacturers in China registered for this device type
108catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (6), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JKA
Manufacturer City Province Registered as Device types
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Weihai Jierui Medical Products Co., Ltd. Weihai Shandong Contract manufacturer 3
Tianjin Hanaco Medical Co., Ltd. Tianjin Tianjin Contract manufacturer 3
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Medicines & Health Products I/ E Co., Ltd. Hangzhou Zhejiang Exporter 41
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Hangzhou Best Valley Medical Technology Co., Ltd. Hangzhou Zhejiang Exporter 20
Zhejiang Kindly Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Jiangsu Rongye Technology Co., Ltd. Yangzhou Jiangsu Manufacturer 16
Yangzhou Medline Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 11
Shanghai Mekon Medical Devices Co., Ltd. Shanghai Shanghai Exporter 11

Showing 12 of 23. All 23 manufacturers in China registered for Tubes, Vials, Systems, Serum Separators, Blood Collection

Record

Regulatory record for S-Monovette®
Listed by Sarstedt Aktiengesellschaft & Co.KG
FDA product code JKA
Device type Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class Class 2
Regulation 21 CFR 862.1675
510(k) BK070029
Record published 2017-01-04
Record revised 2026-03-09 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Packaging Pack of 500, pack of 10, pack of 50
Distribution end date 2026-06-30

Catalogue Numbers

Catalogue numbers for S-Monovette®
Catalogue number Size Per pack Status
04.1927.100 50 In distribution
05.1071.100 50 In distribution
04.1906.100 50 In distribution
01.1634.100 50 In distribution
05.1073.100 50 In distribution
04.1934.100 50 In distribution
03.1524.001 50 In distribution
01.1604.100 50 In distribution
02.1067.001 50 In distribution
01.1602.001 50 In distribution
04.1928.100 50 In distribution
04.1940.100 50 In distribution
02.1063 50 In distribution
04.1902.100 50 In distribution
06.1664.100 50 In distribution
06.1666.100 50 In distribution
06.1666.120 100 In distribution
04.1955.001 50 In distribution
04.1915.100 50 In distribution
03.1068.100 50 In distribution
04.1901.100 50 In distribution
04.1943.100 50 In distribution
02.1066.001 50 In distribution
04.1918.100 50 In distribution
02.1726.001 50 In distribution
04.1914.100 50 In distribution
02.1388.001 50 In distribution
04.1917.100 50 In distribution
01.1608.100 50 In distribution
01.1613.100 50 In distribution
02.1066.100 50 In distribution
04.1951.100 50 In distribution
04.1931.013 50 In distribution
04.1925.001 50 In distribution
06.1665.100 50 In distribution
06.1669.200 50 In distribution
06.1669.100 50 In distribution
02.1065.001 50 In distribution
06.1667.001 50 In distribution
02.1726.021 100 In distribution
04.1913.100 50 In distribution
06.1669.001 50 In distribution
01.1609.201 50 In distribution
04.1943.001 50 In distribution
04.1927.001 50 In distribution
04.1904.100 50 In distribution
04.1900.100 50 In distribution
05.1165.100 50 In distribution
03.1068.102 50 In distribution
06.1668.100 50 In distribution
05.1106.100 50 In distribution
04.1929.100 50 In distribution
02.1065.100 50 In distribution
03.1631.100 50 In distribution
01.1614.100 50 In distribution
04.1905.001 50 In distribution
04.1919.100 50 In distribution
01.1605.100 50 In distribution
04.1913.110 50 In distribution
01.1601.100 50 In distribution
01.1728.001 50 In distribution
04.1935.001 50 In distribution
04.1924.100 50 In distribution
04.1922.100 50 In distribution
05.1167.120 100 In distribution
02.1726.022 100 In distribution
04.1928.200 50 In distribution
03.1397.100 50 In distribution
01.1634 50 In distribution
04.1903.100 50 In distribution
05.1167 50 In distribution
05.1167.100 50 In distribution
04.1907.100 50 In distribution
05.1729 50 In distribution
04.1955.100 50 In distribution
05.1104.100 50 In distribution
04.1931.100 50 In distribution
04.1926.001 50 In distribution
04.1936.100 50 In distribution
04.1910.001 50 In distribution
05.1553.100 50 In distribution
02.1063.100 50 In distribution
01.1604.400 50 In distribution
04.1951.001 50 In distribution
06.1663.100 50 In distribution
01.1624.001 50 In distribution
05.1727.001 50 In distribution
04.1920.100 50 In distribution
01.1606.001 50 In distribution
01.1605.001 50 In distribution
04.1923.001 50 In distribution
05.1081.100 50 In distribution
05.1729.001 50 In distribution
05.1079.100 50 In distribution
06.1659 50 In distribution
04.1933.100 50 In distribution
06.1660.100 50 In distribution
06.1661.100 500 In distribution
04.1917.001 50 In distribution
05.1557.100 50 In distribution
04.1954.200 50 Withdrawn
04.1952.100 50 Withdrawn
04.1953.100 50 Withdrawn
04.1952 50 Withdrawn
04.1954.100 50 Withdrawn
04.1952.200 50 Withdrawn
04.1953.200 50 Withdrawn
03.1628.100 50 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Portex ICU Medical, Inc 182
Vacuette Greiner BIO-ONE Gmbh 106
Jelco ICU Medical, Inc 35
Kbmed KB Medical (Group) Inc. 33
Marketlab Inc Marketlab Incorporated 30
Maveric Medical Maveric Medical LLC 27
Safe-T-Fill® Ram Scientific 23
Improvacuter® Gel & Clot Activator Tube Guangzhou Improve Medical Instruments Co., Ltd. 21
Medline Medline Industries, Inc. 20
Kurin Blood Culture Collection Set Kurin, Inc. 20
Reli Myco Medical Supplies, Inc. 18
icu medical Jiangsu Caina Medical Co., Ltd. 18

Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection

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