Inplast Plastic & Electronics Co., Ltd

FDA Device Registration & Listing · Suzhou New District Jiangsu, CN · Registration 3010392593

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010392593
FEI Number
3010392593
Entity Name
Inplast Plastic & Electronics Co., Ltd
City/State/Country
Suzhou New District Jiangsu, CN
Establishment Address
No 2 Plant, LiJiang Rd #58, Suzhou Science and Technology, Suzhou New District Jiangsu 215153, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Plastikon Healthcare (Owner Number: 10042054)
Owner / Operator Contact Address
3780 Greenway Circle, Lawrence, KS 66046, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MicroAmp

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IDZ Cassettes, Tissue Pathology Class 1 864.3010 2018-01-30
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2013-03-27

Official Correspondent

Sandy Dixon

US Agent Details

Brian Hay Email: brian.hay@Plastikon.com Phone: (785) 3307100

Related Public Records

Same Entity

Plastikon Healthcare
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009840089 PLASTIKON HEALTHCARE Lawrence, KS, US
3008229479 PlasTAT Limited Dongguan City Guangdong, CN
3009974297 Plastikon Industries Hayward, CA, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

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3012760578 ZHUHAI STRONG PRECISION MANUFACTURING CO, LTD. Jin Wan Dist, Zhu Hai Guangdong, CN
3003584784 SHANDON DIAGNOSTICS LIMITED RUNCORN Cheshire East, GB
3012462466 MIDA PRECISION MOLD CO.,LTD BEN LUC DISTRICT Long An, VN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010392593. Last updated year: 2026. Please use registration number 3010392593 when referencing this establishment in official correspondence.
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