Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089857

FEI Number

3030089857

Entity Name

Nordes Sp. z o.o.

City/State/Country

Wroclaw Dolnoslaskie, PL

Establishment Address

str. Ziemniaczana 15, Wroclaw Dolnoslaskie 52-127, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Auditdata A/S (Owner Number: 10032598)

Owner / Operator Contact Address

Wildersgade 10B, Copenhagen, DK-84 1408, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

2001 Primus Video Otoscope - PVO Primus Hearing instrument test unit - PHITU OTOPro 2000 Primus HIT Pro HIT Unit 2005-1 HIT Unit Measure by Otometrics - HIT Unity 3 HIT Unit HIT - Measure by Otometrics 3000 Real Ear 3000 Real Ear - IN1 IN1 Insert Earphone 2000-1 Fitting Unit - Measure by Otometrics 3000 Real Ear - CA1 CA1 HF Audiometric Headphone 3000 Real Ear - SA1 Entomed SA 203 Entomed SA 201 2000 Primus Ice Entomed SA 204 2000 Primus fitting unit + - PFU+ Entomed SA 202 OTOSphere OTOPod 2000 Primus fitting unit Pro - PFU Pro Amplitude T-Series 2000 Primus fitting unit - PFU Unity 4 2000-1 FU - Unity 4 Measure 2000-1 FU - Measure by Otometrics 2000-1 FU - Measure 2000-1 Fitting Unit SA1 HB-7 Headphone 2000-1 Fitting Unit - Unity 4 SA1 HBA Headphone SA1 RE-7 Headphone 2000-1 Fitting Unit - Measure 2000-1 FU IN1 Insert Earphone CA1 Audiometric Headphone BC1 Bone Conductor 3000 Real Ear - IN1 3000 Real Ear 3000 Real Ear - BC1 Measure by Otometrics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2014-08-18
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2014-12-09
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	Class 1	874.1100	2025-12-21
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2010-05-28

Official Correspondent

Christian Holmelund

US Agent Details

Christian Holmelund Business: Auditdata LLC Email: compliance@auditdata.com Phone: (610) 7689300

Related Public Records

Same Entity

Auditdata A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004052117	Auditdata, LLC	Pottstown, PA, US
3013596041	Inission Syd AB (Malmo AB)	Malmo Skane, SE
3008386587	Auditdata A/S	Copenhagen Hovedstaden, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030089857. Last updated year: 2026. Please use registration number 3030089857 when referencing this establishment in official correspondence.