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TRACOE MEDICAL GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80104853003361161TRACOE MEDICAL GMBH1N2026-01-01REICHELSHEIMER STR. 1/3 NIEDER-OLM Rhineland-Palatinate DE D-55268

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04035324012176TRACOE® care - TRACOE cleaning brushes with wool tip+49613691690info@tracoe.com
04035324012183TRACOE® care - TRACOE cleaning brushes with wool tip+49613691690info@tracoe.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
92351342489986K961449TRACHEOSTOMY TUBES TRACOE-FLEXJOH1996-09-13
92351029249966K893866HOOD PEDIATRIC TRACHEOSTOMY TUBEBTO1989-08-07
92351558343363K781729TRACHEOTOMY TUBESBTO1978-10-24
92351961089620K203362TRACOE varioJOH2021-08-05
92351051010760K172720TRACOE silcosoft Tracheostomy TubeJOH2018-04-27
92351310065735K152865TRACOE smart Cuff ManagerBSK2016-09-27
92351214496678K152778TRACOE Cuff Pressure MonitorBSK2016-12-21
92351615999636K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470BTO2005-10-25
92352019412343K043160TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SOJOH2005-02-18
92351340245308
92351721266705
92351028860049
92351049225832
92351378893377
92351418991521
92351463572036
92351513332618
92351539967267
92351756786690
92351833841216

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOH42021-08-05
BTO32005-10-25
BSK22016-12-21

PMN#

GUDID#

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