Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012850581

FEI Number

3012850581

Entity Name

ERGO-TEC GMBH

City/State/Country

Wilhelmsdorf Bavaria, DE

Establishment Address

Gewerbestr. 2, Wilhelmsdorf Bavaria 91489, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ergo-Tec GmbH (Owner Number: 10060664)

Owner / Operator Contact Address

Gewerbestr. 2, Wilhelmsdorf, DE-BY 91489, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biometer Table 1628 Opthalmic Table 2151 Unity Dx Table 1721

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2019-06-09

Official Correspondent

Alexander Duersch

US Agent Details

Bernhard Wandernoth Business: BEE Systems, Inc. Email: prrc@bee.systems Phone: (818) 6481773

Related Public Records

Same Entity

Ergo-Tec 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 3012850581. Last updated year: 2026. Please use registration number 3012850581 when referencing this establishment in official correspondence.