Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013584824

FEI Number

3013584824

Entity Name

ERGOMEDI LTD.

City/State/Country

Espoo Uusimaa, FI

Establishment Address

Linnoitustie 4A, Espoo Uusimaa 02600, FI

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ErgoMedi Ltd. (Owner Number: 10053799)

Owner / Operator Contact Address

Linnoitustie 4A, Espoo, FI-18 02600, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ErgoFinger

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2017-01-12

Official Correspondent

Gunilla Taddeo

US Agent Details

Dario Taddeo Business: ErgoMedi LLC Email: dario.taddeo@ergomedi.com Phone: (386) 5970143

Related Public Records

Same Entity

ErgoMedi 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 3013584824. Last updated year: 2026. Please use registration number 3013584824 when referencing this establishment in official correspondence.