BEMER Int. AG

Triesen, LI

BEMER Int. AG appears in FDA device records in Triesen, LI. FDA records list 4 510(k) clearances between 2017-02-22 and 2023-09-23, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 4 510(k) clearances for BEMER Int. AG between 2017 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.

Clearances by year, as a table

510(k) clearance decisions for BEMER Int. AG, by decision year
Year	Clearances
2017	1
2021	1
2023	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K223919	B.Light Clear Evo and B.Light Restore Evo	OHS	Substantially Equivalent	2023-09-23
K231368	Bemer Therapy System Evo	NGX	Substantially Equivalent	2023-06-09
K210174	BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set	NGX	Substantially Equivalent	2021-02-04
K151834	BEMER Classic Set, BEMER Pro-Set	NGX	Substantially Equivalent	2017-02-22

Registered establishments

FDA registered establishments for BEMER Int. AG, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3009102830	3009102830	BEMER Int. AG	Austrasse 15, Triesen 9495 LI	2026	NGX OHS OLP

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1105-2021	Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)	There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.	Class II	2021-01-13	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets BEMER Int. AG edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain