BIOTECH EUROPE MEDITECH INC LTD

FDA Device Registration & Listing · Roscommon, IE · Registration 3016942176

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016942176
FEI Number
3016942176
Entity Name
BIOTECH EUROPE MEDITECH INC LTD
City/State/Country
Roscommon, IE
Establishment Address
AF2 IDA Business and Technology Park, Gallowstown, Roscommon F42P862, IE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Biotech Europe Meditech Inc Ltd (Owner Number: 10085821)
Owner / Operator Contact Address
AF 2, IDA Business & Technology Park,, Gallowstown,, Roscommon, IE-RN F42P862, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IC-8 Apthera IOL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
POE Extended Depth Of Focus Intraocular Lens Ophthalmic Class 3 886.3600 2022-08-15

Official Correspondent

Bhaumikkumar Patel

US Agent Details

Ramesh Sedhain Business: Bausch & Lomb Incorporated Email: ramesh.sedhain@bausch.com Phone: (727) 7246729

Related Public Records

Same Entity

Biotech Europe Meditech Inc Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3015456951 Alcon Laboratories Belgium Puurs-Sint-Amands Antwerpen, BE
3007530141 Alcon Research, LLC Lesage, WV, US
3002807314 Synergy Health Ireland Ltd Tullamore Offaly, IE
9681121 PT. CIBA VISION BATAM BATAM ISLAND Riau, ID
3012236936 Johnson & Johnson Surgical Vision, Inc. Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016942176. Last updated year: 2026. Please use registration number 3016942176 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.