Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031572059

FEI Number

3031572059

Entity Name

TissueGUARD

City/State/Country

Dresden Saxony, DE

Establishment Address

Hohe Str 6, Dresden Saxony 01069, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

TissueGUARD GmbH (Owner Number: 10090875)

Owner / Operator Contact Address

Trienter str 16, Dresden, DE-SN 01217, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TissueGUARD Tip Closure Cap for DMEK Injector TissueGUARD DMEK/DSAEK Washing GUARD TissueGUARD DMEK Injector SET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-04-18
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-05-28

Official Correspondent

Mikhail Tsurkan

US Agent Details

Emerance Gummels Business: EMG Consulting Services Email: emerance@emgconsultingservices.com Phone: (305) 4408072

Related Public Records

Same Entity

TissueGUARD 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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

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.

Similar Registrations

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2431166	Sklar Corporation	West Chester, PA, US
3036504234	Solventum US LLC	Flemington, NJ, US
3010419931	SIGNA MEDICAL, INC.	Long Beach, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031572059. Last updated year: 2026. Please use registration number 3031572059 when referencing this establishment in official correspondence.