Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032763783

FEI Number

3032763783

Entity Name

Solventum Poland Manufacturing SP. ZO.O

City/State/Country

Wroclaw Dolnoslaskie, PL

Establishment Address

Site Wroclaw Ul. Kwidzynska 6, Wroclaw Dolnoslaskie 51-416, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Solventum US LLC (Owner Number: 10091183)

Owner / Operator Contact Address

12930 IH 10 West, San Antonio, TX 78249, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPTICLUDE ORTHOPTIC EYE PATCH OPTICLUDE 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch 3M(TM) Nexcare(TM) Gentle Removal Eye Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2002-07-11
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2019-04-01
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2019-04-01
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1978-03-31
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-07-10

Official Correspondent

JEFFERY SCHORR

US Agent Details

JEFFERY SCHORR Business: SOLVENTUM US LLC Email: RegulatoryRequests@solventum.com Phone: (210) 2556721

Related Public Records

Same Entity

Solventum US LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004943440	3M Purification, S. de R.L. de C. V.	San Luis Potosi Mexico, MX
3003775292	KCI POLYMEDICS BV	PEER Limburg, BE
3036108847	Solventum US LLC	Eden Prairie, MN, US
3038988287	Solventum Canada Limited	Morden Manitoba, CA
3014209526	KCI NORTH IX (Technical Services Center)	San Antonio, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3010195489	TOYO RESIN CORPORATION	FUJI Shizuoka, JP
3004740112	OVIK Health	Columbus, NC, US
2182345	BIRD & CRONIN, LLC	Eagan, MN, US
3017896419	FESUN SHANGHAI CO., LTD.	shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032763783. Last updated year: 2026. Please use registration number 3032763783 when referencing this establishment in official correspondence.