Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613277

FEI Number

3003756809

Entity Name

WIPAK OY

City/State/Country

NASTOLA Etela-Karjala, FI

Establishment Address

WIPAKTIE 2, NASTOLA Etela-Karjala FI 15561, FI

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

K953776

PMA Number

N/A

All Registered Proprietary Names

STERIKING STERIKING STERIKING STERIKING Steriking See&Peel Steriking See&Peel STERIKING STERIKING 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	2023-09-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-06-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-09-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-09-29
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2008-02-21
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2008-02-21
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-12-03
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-03-25
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
3011533888	Wipak Packaging (Changshu) co., Ltd.	Changshu Jiangsu, CN

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

Similar Registrations

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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 9613277. Last updated year: 2026. Please use registration number 9613277 when referencing this establishment in official correspondence.