Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010935

FEI Number

3002807646

Entity Name

medi-plus Instrumente GmbH

City/State/Country

TUTTLINGEN-NENDINGEN Baden-Wurttemberg, DE

Establishment Address

11 SATTLERSTRASSE, TUTTLINGEN-NENDINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

medi-plus Instrumente GmbH (Owner Number: 10027887)

Owner / Operator Contact Address

Sattlerstrasse 11, Tuttlingen, DE-BW 78532, 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
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-12-11
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2018-02-14
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2008-12-11
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2008-12-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-06-02
HWJ	Awl	Orthopedic	Class 1	888.4540	2018-03-05
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-02-14
HXW	Bender	Orthopedic	Class 1	888.4540	2008-12-11
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2008-12-11
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-03-05
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-18
EWY	Mediastinoscope, Surgical	Ear, Nose, Throat	Class 2	874.4720	2022-06-02
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2008-12-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-18
HXB	Probe	Orthopedic	Class 1	888.4540	2018-03-05
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-02-14
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2008-12-11

Official Correspondent

Florian Mattes

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

medi-plus Instrumente 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010935. Last updated year: 2026. Please use registration number 8010935 when referencing this establishment in official correspondence.