Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010208143

FEI Number

3010208143

Entity Name

MIELE & CIE. KG

City/State/Country

Bielefeld North Rhine-Westphalia, DE

Establishment Address

Mielestrasse 2, Bielefeld North Rhine-Westphalia 33611, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Miele & Cie. KG (Owner Number: 10042734)

Owner / Operator Contact Address

Carl-Miele-Strasse 29, Guetersloh, DE-NW 33332, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PG 8592 PG 8582 CD PG 8581 PWD 8692 Steelco DS 5011 PWA 8672 Steelco DS 5010 Steelco DS 5020 PWD 8682

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2012-12-21

Official Correspondent

Andreas Broemmelhaus

US Agent Details

Douglas Konke Business: Miele Inc. Email: dkonke@miele.com Phone: (609) 3753134

Related Public Records

Same Entity

Miele & Cie. KG

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Similar Registrations

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3012006473	REHABILITATION EQUIPMENT ASSOCIATES, INC	Manchester, NH, US
3005544459	STEELCO S.P.A.	Riese Pio X Treviso, IT
3018520804	ZHONGSHAN SUNCLEAN CO.,LTD	Zhongshan Guangdong, CN
8021896	ALBERT BROWNE LTD.	LEICESTER, GB
3017293064	XIAMEN FORSOUND HEARING TECHNOLOGY CO.,LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010208143. Last updated year: 2026. Please use registration number 3010208143 when referencing this establishment in official correspondence.