Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006154292

FEI Number

3006154292

Entity Name

FENTEXMEDICAL GMBH

City/State/Country

NEUHAUSEN, BW Baden-Wurttemberg, DE

Establishment Address

TAKE-OFF GEWERBEPARK 2, NEUHAUSEN, BW Baden-Wurttemberg D 78579, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

FENTEX MEDICAL GMBH (Owner Number: 9093406)

Owner / Operator Contact Address

TAKE-OFF GEWERBEPARK 2, --, NEUHAUSEN, BW, DE-NOTA D 78579, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MANUAL SURGICAL INSTRUMENT LIGATURE PASSING AN MANUAL SURGICAL INSTRUMENTS MICROSURGICAL EAR PICKS ENT PROBES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2006-10-10
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2006-10-10
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-12-15
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-10-10
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2006-10-10
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2006-10-10
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2006-10-10
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2006-10-10
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2006-10-10
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2006-10-10
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2006-10-10
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2006-10-10
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2006-10-10

Official Correspondent

Bert Sutter

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

FENTEX 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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Similar Registrations

Registration Number	Establishment Name	Location
3027828125	MAJiK MEDICAL SOLUTIONS PRIVATE LIMITED	Hyderabad Telangana, IN
3005440795	XINHUA SURGICAL INSTRUMENT CO. LTD.	ZIBO Shandong, CN
2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
9615857	INSTRUMENTARIUM SURGICAL CORP., INC.	TERREBONNE Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006154292. Last updated year: 2026. Please use registration number 3006154292 when referencing this establishment in official correspondence.