MacoSeal SE160

The MacoSeal SE160 is a specially designed tube sealer for dual purpose use. The device can work as a stand-alone tube sealer and also can be easily configured as a multi-head sealing unit.…

Registry build 21.09.26

The MacoSeal SE160 is a specially designed tube sealer for dual purpose use. The device can work as a stand-alone tube sealer and also can be easily configured as a multi-head sealing unit. The devices can be linked in series as many number of devices as users want at spacing between 70 to 95 mm.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangxi (1), Hunan (1).

Chinese manufacturers registered for FDA product code KSD
Manufacturer City Province Registered as Device types
Guangxi Ehall Medical Technology Co., Ltd. Nanning Guangxi Manufacturer 17
Changsha Yingtai Instrument Co., Ltd. Changsha Hunan Manufacturer 7

Record

Regulatory record for MacoSeal SE160
Listed by Centron Corporation, South Korea
FDA product code KSD
Device type Device, Heat-Sealing
Device class Class 1
Regulation 21 CFR 864.9750
Establishment Manufacturer
Premarket notification Exempt
Record published 2020-04-03
Record revised 2022-06-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Storage Handling environment temperature 0 to 40 °C; Handling environment humidity 30 to 80 % RH
Sizes Weight 4.4 kg; length 6.9 cm; height 24.5 cm; depth 35 cm

Catalogue Numbers

Catalogue numbers for MacoSeal SE160
Catalogue number Size Status
SE160 Weight 4.4 kg In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Yingtai Changsha Yingtai Instrument Co., Ltd. 19
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CrocClamp™ (Non-Reopening Clamp) ITL Asia Pacific SDN BHD 1
MacoSeal PS2-AS Maco Pharma 1
Roma Cordless handheld sealer for blood bag tubing Delcon SRL 1
Rapid Seal Tube Sealer SE470 Centron Corporation 1
Rapid Seal Tube Sealer SE540 Centron Corporation 1
Roma Charger Delcon SRL 1

Showing 12 of 24. All products under Device, Heat-Sealing

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