Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011533888

FEI Number

3011533888

Entity Name

Wipak Packaging (Changshu) co., Ltd.

City/State/Country

Changshu Jiangsu, CN

Establishment Address

No. 88 Fuchunjiang Road, Changshu New&Hi-Tech Industrial Development Zone, Changshu Jiangsu 215533, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WIPAK OY (Owner Number: 9035122)

Owner / Operator Contact Address

WIPAKTIE 2, --, NASTOLA, FI-NOTA FI-15560, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973827

PMA Number

N/A

All Registered Proprietary Names

Steriking See&Peel Steriking See&Peel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2008-02-21
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2008-02-21

Official Correspondent

Tanja Venalainen

US Agent Details

Emily Valerio Business: Healthmark Industries Co., Inc. / Getinge Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

WIPAK OY

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9613277	WIPAK OY	NASTOLA Etela-Karjala, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

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9616096	La Ada de Acuna	CIUDAD DE ACUNA Coahuila, MX
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
8030674	ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.	Tlalnepantla, Estado de Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011533888. Last updated year: 2026. Please use registration number 3011533888 when referencing this establishment in official correspondence.