Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015218462

FEI Number

3015218462

Entity Name

SHENGZYI ENTERPRISE CO., LTD

City/State/Country

Kaohsiung city, TW

Establishment Address

705-1 ZhongShan Road, Section 1, HuNei Dist, Kaohsiung city 82944, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shengyin Xiamen Plastic Products Co., Ltd. (Owner Number: 10044721)

Owner / Operator Contact Address

No.6-10 Neitianxi Rd, Xiangbei Park, XiangAn, Xiamen, CN-FJ 361101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

specimen bag, adhesive bag, ziplock bag, open-ended bag, sandwich bag, saddle bag specimen bag, adhesive bag, ziplock bag, open-ended bag, sandwich bag, saddle bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2013-07-18
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2013-07-18

Official Correspondent

No official correspondent registered.

US Agent Details

Suny Chen Email: sunychen@hotmail.com Phone: (215) 6816149

Related Public Records

Same Entity

Shengyin Xiamen Plastic Products Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015218462. Last updated year: 2026. Please use registration number 3015218462 when referencing this establishment in official correspondence.