Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043441

FEI Number

3007714917

Entity Name

Denzel Medical GmbH & Co. KG

City/State/Country

NEUHAUSEN Baden-Wurttemberg, DE

Establishment Address

TAKE-OFF GEWERBEPARK 65, NEUHAUSEN Baden-Wurttemberg 78579, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Denzel Medical GmbH & Co. KG (Owner Number: 9001458)

Owner / Operator Contact Address

TAKE-OFF GEWERBEPARK 65, --, NEUHAUSEN, DE-BW 78579, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2005-03-28
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2012-12-18
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1990-10-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-03-25
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2021-04-12
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2018-11-19
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-08-13
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2004-09-16
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-12-18
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2024-04-18
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2017-11-15
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-02-19
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-04-18
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-09-16
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2025-02-07
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2012-12-18
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2015-10-12
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2025-04-29
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-03-25
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2020-11-23
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-09-16
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2003-08-13
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2013-05-15
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2016-10-17
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1990-10-16
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-10-17

Official Correspondent

LOTHAR DENZEL

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

Denzel Medical GmbH & Co. KG

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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043441. Last updated year: 2026. Please use registration number 8043441 when referencing this establishment in official correspondence.