Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010965020

FEI Number

3010965020

Entity Name

meluna

City/State/Country

Haundorf Bavaria, DE

Establishment Address

Brand 57, Haundorf Bavaria 91729, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Me Luna GmbH (Owner Number: 10047192)

Owner / Operator Contact Address

Brand 57, Haundorf, DE-BY 91729, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140626

PMA Number

N/A

All Registered Proprietary Names

MeLuna Cup Me Luna Sport MeLuna Classic MeLuna Sport Me Luna Classic Me Luna Cup Me Luna

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2014-07-16

Official Correspondent

Frank Krueger

US Agent Details

Karin Kohler Business: DOMINO PADS Email: karin@meluna-usa.com Phone: (210) 3918558

Related Public Records

Same Entity

Me Luna GmbH

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 3010965020. Last updated year: 2026. Please use registration number 3010965020 when referencing this establishment in official correspondence.