Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012605350

FEI Number

3012605350

Entity Name

SOTERIA MEDICAL B.V.

City/State/Country

Arnhem Gelderland, NL

Establishment Address

Meander 251, Arnhem Gelderland 6825 MC, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Soteria Medical B.V. (Owner Number: 10051502)

Owner / Operator Contact Address

Meander 251, Arnhem, NL-GE 6825 MC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RCM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWW	Table, Operating-Room, Pneumatic	General, Plastic Surgery	Class 1	878.4960	2016-03-27

Official Correspondent

Jan Sabisch

US Agent Details

Jan Sabisch Business: Jan Sabisch Consulting LLC Email: jan.sabisch@gmail.com Phone: (518) 5109754

Related Public Records

Same Entity

Soteria Medical B.V.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1643264	SMITH & NEPHEW INC.	OKLAHOMA CITY, OK, US
3003749961	INDUSTRIAS METALICAS LOS PINOS SA	ITAGUI Antioquia, CO
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3012240979	BRUSAFERRI & C. SRL	Casalbuttano Cremona, IT
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012605350. Last updated year: 2026. Please use registration number 3012605350 when referencing this establishment in official correspondence.