Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007221462

FEI Number

3007221462

Entity Name

safemed medical devices s.r.o.

City/State/Country

Prague Praha, Hlavni Mesto, CZ

Establishment Address

Trabantska 292, Prague Praha, Hlavni Mesto 190 15, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

sfm medical devices GmbH (Owner Number: 9088579)

Owner / Operator Contact Address

Brueckenstrasse 5, --, Waechtersbach, DE-NOTA 63607, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

nextaro® va, 15mm, 5µm (REF number: 20037) nextaro® va 13, 5µm Filter (REF number 20042) PROBE, RADIOFREQUENCY LESION nexoderm® Dermal Curette nextaro® v, 20/20 (REF number 20027) nextaro® v, 20/20, 5µm (REF number 20040) nextaro® v 20/32 (REF number 20035)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2019-04-29
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-09-09
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2024-12-30
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2024-12-30
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2009-08-11
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2009-08-11
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2020-07-13
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-06-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-04-22
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

Ryan O'Callaghan Business: Phil Triolo and Associates LC Email: ryano@philt.com Phone: (801) 5732651

Related Public Records

Same Entity

sfm medical devices GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000632857	SFM Medical Devices GmbH	Waechtersbach Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007221462. Last updated year: 2026. Please use registration number 3007221462 when referencing this establishment in official correspondence.