Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044057

FEI Number

3003445992

Entity Name

Vitalitec International Medizintechnik GmbH

City/State/Country

BALGHEIM Baden-Wurttemberg, DE

Establishment Address

STEIGAECKER 20, BALGHEIM Baden-Wurttemberg 78582, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

VITALITEC INTERNATIONAL MEDIZINTECHNIK GMBH (Owner Number: 9005335)

Owner / Operator Contact Address

Steigaecker 20, --, BALGHEIM, DE-BW D-78582, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K944268

PMA Number

N/A

All Registered Proprietary Names

Enlarging Bur Hudson brace, handle only Aesculap Forceps Grasping and Dissecting Forceps, Scissors, endoscopy Forceps, Biopsy, Gynecological Laparoscopic Instruments, monopolar Suction Tip Wire Saw INSTRUMENTS FOR LIGATURE Elevator Arthroscopic sheaths/trocars Needle Holder Dissecting scissors Suction Irrigation devices, trocar sheaths, ports and accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2017-07-15
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-07-14
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-04-01
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2017-07-18
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2017-07-15
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-12-07
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2009-03-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-12-07
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2017-07-15
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2017-07-15
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1992-06-04
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-15
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2017-04-01
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1992-06-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-06-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-03-27
HTX	Rongeur	Orthopedic	Class 1	888.4540	2010-05-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

VITALITEC INTERNATIONAL MEDIZINTECHNIK 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
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044057. Last updated year: 2026. Please use registration number 8044057 when referencing this establishment in official correspondence.