Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019543601

FEI Number

3019543601

Entity Name

BEBIG MEDICAL GMBH

City/State/Country

Berlin, DE

Establishment Address

Karower Damm 9, Berlin 13129, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BEBIG Medical GmbH (Owner Number: 10081915)

Owner / Operator Contact Address

Karower Damm 9, Berlin, DE-BE 13129, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141900

PMA Number

N/A

All Registered Proprietary Names

SagiNova Applicators, Transfer Tubes and Accessories SagiNova SagiPlan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2021-05-26
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2021-05-26

Official Correspondent

Siddharth Jani

US Agent Details

Natalia Khramova Business: Mick Radio-Nuclear Instruments, Inc. Email: natalia.khramova@bebigmedical.com Phone: (914) 6670291

Related Public Records

Same Entity

BEBIG Medical GmbH

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
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2012	Elekta, Inc.	2	Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017	RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden	2	RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

Similar Registrations

Registration Number	Establishment Name	Location
2032338	Merit Medical Systems, Inc.	ALISO VIEJO, CA, US
3007200016	Hologic Surgical Products Costa Rica, S.R.L.	El Coyol Alajuela, CR
3016602874	Varian Medical Systems Haan GmbH	Haan North Rhine-Westphalia, DE
9611894	NUCLETRON B.V.	VEENENDAAL Utrecht, NL
2431392	MICK RADIO-NUCLEAR INSTRUMENTS, INC.	MOUNT VERNON, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019543601. Last updated year: 2026. Please use registration number 3019543601 when referencing this establishment in official correspondence.