Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005813597

FEI Number

3005813597

Entity Name

SIMEX MEDIZINTECHNIK GMBH

City/State/Country

Deisslingen Baden-Wurttemberg, DE

Establishment Address

Brueckstr. 30/1, Deisslingen Baden-Wurttemberg 78652, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SIMEX MEDIZINTECHNIK GMBH (Owner Number: 9086230)

Owner / Operator Contact Address

Brueckstr. 30/1, --, DEISSLINGEN, DE-NOTA 78652, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dilator, Tracheal Depressor, Tongue, Non-Surgical Hammer, Surgical Laryngoscope, Rigid Forceps, General & Plastic Surgery SIMEX200 SIMEX300 Clamp Needle, Suturing, Reusable Bit, Drill Speculum, Vaginal, Metal Retractor, All Types Tube, Tonsil Suction Gouge, Surgical, General & Plastic Surgery Dilator, Catheter Mallet Syringe, Periodontic, Endodontic, Irrigating Hemostat Forceps, Rongeur, Surgical Cutter, Wire Scissors, Ophthalmic Guide, Needle, Surgical Scissors, General, Surgical Handle, Scalpel Elevator Instrument, Manual, General Obstetric-Gynecologic Scaler, Periodontic Dilator, Cervical, Fixed Size Mirror, Mouth cuff M cuff S Instrument, Cast Application/Removal, Manual Chisel, Surgical, Manual Spatula, Surgical, General & Plastic Surgery Hook, Surgical, General & Plastic Surgery

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2022-08-31
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2022-08-30
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-08-30
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2022-08-30
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-30
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2012-09-17
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-08-30
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2022-08-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-08-30
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2022-08-30
EIG	Retractor, All Types	Dental	Class 1	872.4565	2022-08-30
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-08-22
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2022-08-31
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-30
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-08-30
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2022-08-31
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2022-08-30
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2022-08-30
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2022-08-30
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2022-08-31
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-08-30
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-08-30
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-08-31
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-08-30
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2022-08-30
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2022-08-31
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2022-08-30
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2022-08-30
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2022-08-30
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2014-10-06
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2022-08-31
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2022-08-30
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-30
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-30

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

SIMEX 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

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
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005813597. Last updated year: 2026. Please use registration number 3005813597 when referencing this establishment in official correspondence.