Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005049692

FEI Number

3005049692

Entity Name

RAPID BIOMEDICAL GMBH

City/State/Country

RIMPAR Bavaria, DE

Establishment Address

KETTELERSTR. 3-11, RIMPAR Bavaria 97222, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RAPID BIOMEDICAL GMBH (Owner Number: 9070724)

Owner / Operator Contact Address

Kettelerstrasse 3-11, RIMPAR, DE-BY 97222, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191539

PMA Number

N/A

All Registered Proprietary Names

1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811 3 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630 23Na 1Tx32Rx Head 7T 31P/1H TxRx Flex Loop 7T 16 Ch AI Breast Coil 3 T 16 Ch AI Breast Coil 1.5 T P-140-Flex Coil Na-140-Flex Coil C-140-Flex Coil 13C/1H Head Coil 23Na/1H Head Coil 31P/1H Head Coil

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-11-28
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-02-22
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-02-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-02-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2008-12-05
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-03-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-02-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

Dana Parsons Business: RAPID MR International, LLC Email: dana.parsons@rapidmri.com Phone: (614) 4866300

Related Public Records

Same Entity

RAPID BIOMEDICAL 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
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

Similar Registrations

Registration Number	Establishment Name	Location
3012169560	SIARON MEDICAL LTD	Vancouver British Columbia, CA
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL
3010949642	GE HEALTHCARE (TIANJIN) COMPANY LIMITED	Tianjin, CN
3006369484	NEOCOIL, LLC	Pewaukee, WI, US
3010703925	MAKAR CONSULTING PTY LTD	Belrose New South Wales, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005049692. Last updated year: 2026. Please use registration number 3005049692 when referencing this establishment in official correspondence.