MacoPress Smarter

The MacoPress Smarter (MPS) and DMS consist of two parts: the MacoPress Smarter device and the DMS Management software. The MacoPress Smart is intended as an automated blood component…

Registry build 21.09.26

The MacoPress Smarter (MPS) and DMS consist of two parts: the MacoPress Smarter device and the DMS Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed.

3manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KSS
Manufacturer City Province Registered as Device types
Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. Shenzhen Guangdong Contract manufacturer 1
Ningbo Risenmed Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 42
Jiangsu Goju Identification Technology Co., Ltd. Yancheng Jiangsu Contract manufacturer 6

Record

Regulatory record for MacoPress Smarter
Listed by Delcon SRL, Italy
FDA product code KSS
Device type Supplies, Blood-Bank
Device class Class 1
Regulation 21 CFR 864.9050
Establishment Contract manufacturer, Manufacturer
Record published 2020-07-06
Record revised 2022-12-08 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for MacoPress Smarter
Catalogue number Size Status
MacoPress Smart Smarter and DMS WIFI Module no breaker In distribution
MacoPress Smart Smarter and DMS Ethernet Module – no breaker In distribution
MacoPress Smart Smarter and DMS WIFI Module – with breaker module In distribution
MacoPress Smart Smarter and DMS Ethernet Module – with breaker module In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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RadTag Radtag Technologies, Inc. 12
Cascade Musculoskeletal Transplant Foundation 5
MTS Micro Typing Systems, Inc. 5
Capture Liss Immucor, Inc. 5
GPS® III Platelet Concentration System Biomet Biologics, LLC 4
Marketlab Inc Marketlab Incorporated 4
Capture-P Immucor, Inc. 3
GPS® III Biomet Biologics, LLC 2
Typesafe 2.0 Typenex Medical, LLC 2
Capture-P Indicator Red Cells Immucor, Inc. 2
Typesafe Typenex Medical, LLC 2

Showing 12 of 48. All products under Supplies, Blood-Bank

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