Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005071827

FEI Number

3005071827

Entity Name

Ermis MedTech

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

DORNIERSTRASSE 49, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Ermis MedTech GmbH (Owner Number: 9071497)

Owner / Operator Contact Address

DORNIERSTRASSE 49, --, 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
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-03-18
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-18
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2005-03-18
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-11-30
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-07-15
HXB	Probe	Orthopedic	Class 1	888.4540	2010-11-30
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-18
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2010-05-07

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Ermis MedTech 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
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
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

Similar Registrations

Registration Number	Establishment Name	Location
2027754	OSTEOMED	ADDISON, TX, US
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
3004892425	SPARTECH INSTRUMENTS & CO.	SIALKOT, PUNJAB, PK
3004111573	Sterigenics US LLC	Grand Prairie, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005071827. Last updated year: 2026. Please use registration number 3005071827 when referencing this establishment in official correspondence.