Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038620598

FEI Number

3038620598

Entity Name

PT. BEURER INDONESIA TECHNOLOGY

City/State/Country

Kab Kendal Jawa Tengah, ID

Establishment Address

Kawasan Industri Kendal, Jalan Lokapala Nomor 3,, Desa Wonorejo, Kec. Kaliwungu, Kab Kendal Jawa Tengah 51372, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT. Beurer Indonesia Technology (Owner Number: 10093565)

Owner / Operator Contact Address

Kawasan Industri Kendal, Jalan Lokapala Nomor 3,, Desa Wonorejo, Kec. Kaliwungu, Kab Kendal, ID-JT 51372, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IL60 Beurer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-09-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-07-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-11-26
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2025-11-26
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-06-04

Official Correspondent

Akhmad Darsono

US Agent Details

Nathifa Bradshaw Business: Beurer North America LP Email: nathifa@beurer.com Phone: (954) 2828108

Related Public Records

Same Entity

PT. Beurer Indonesia Technology

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

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3016214547	RED DOT LED LIGHTING LIMITED	Shenzhen Guangdong, CN
3014296246	PHOTON THERAPY SYSTEMS (PTY) LTD	Pretoria Gauteng, ZA
3033920804	CHONGQING YUYI TECHNOLOGY., CO., LTD.	Chongqing, CN
3015466811	REV-MED INC.	Yongin-si Gyeonggi, KR
3035879449	DONGGUAN JIAYU ELECTRICAL CO.,LTD	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038620598. Last updated year: 2026. Please use registration number 3038620598 when referencing this establishment in official correspondence.