Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001227772

FEI Number

3001227772

Entity Name

MOLTENO OPHTHALMIC LTD.

City/State/Country

DUNEDIN Otago, NZ

Establishment Address

152 FREDERICK ST., DUNEDIN Otago 9016, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MOLTENO OPHTHALMIC LTD. (Owner Number: 9030682)

Owner / Operator Contact Address

152 FREDERICK ST., --, DUNEDIN, NZ-OTA 9016, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K902489

PMA Number

N/A

All Registered Proprietary Names

Molteno Molteno TM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2015-12-10
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2015-05-21

Official Correspondent

Janine Hunter

US Agent Details

Papa Win Business: Nova Eye Inc. Email: pwin@nova-eye.com Phone: (510) 2911303

Related Public Records

Same Entity

MOLTENO OPHTHALMIC LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001227772. Last updated year: 2026. Please use registration number 3001227772 when referencing this establishment in official correspondence.