Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003485793

FEI Number

3003485793

Entity Name

OTE PHARMA SOL bv

City/State/Country

UDEN Noord-Brabant, NL

Establishment Address

VLUCHTOORD 38, UDEN Noord-Brabant 5406XP, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OTE PHARMA SOL bv (Owner Number: 9106180)

Owner / Operator Contact Address

VLUCHTOORD 38, --, UDEN, NL-NOTA 5406XP, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2007-08-22

Official Correspondent

No official correspondent registered.

US Agent Details

Kathi Baade Baade Business: K & K Consulting Email: k1978@santel.net Phone: (605) 9993356

Related Public Records

Same Entity

OTE PHARMA SOL bv

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.

Similar Registrations

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9617489	TAIWAN BIOTECH CO., LTD.	TAOYUAN, TW
1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003485793. Last updated year: 2026. Please use registration number 3003485793 when referencing this establishment in official correspondence.