Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009747883

FEI Number

3009747883

Entity Name

Esco Medical Technologies, UAB

City/State/Country

Ramuciai Kauno Apskritis, LT

Establishment Address

Gamybos g. 2, Ramuciai Kauno Apskritis 54468, LT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Esco Medical Technologies, UAB (Owner Number: 10041499)

Owner / Operator Contact Address

Gamybos g. 2, Ramuciai, LT-KU 54468, LT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133742

PMA Number

N/A

All Registered Proprietary Names

MIRI TL12 Multi-zone ART Workstation Mini MIRI Dry Mini MIRI Humidity MIRI Humidity MIRI II-12 MIRI M (MIRI M-C, MIRI M-D) CultureCoin MIRI TL6 XQ-1 Esco MIRI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUB	Accessory, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6120	2019-03-12
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2016-05-10
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2016-05-10
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2014-05-05

Official Correspondent

Aurimas Jonaitis

US Agent Details

Alex Atmadi Email: alex.atmadi@escolifesciences.com Phone: (267) 7365218

Related Public Records

Same Entity

Esco Medical Technologies, UAB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number	Establishment Name	Location
3025301749	TMRW LIFE SCIENCES, Inc.	New York, NY, US
3017838619	WATANABE EQUIPAMENTOS MEDICOS	Cravinhos, Sao Paulo, BR
3007459332	ASTEC CO., Ltd.	Kasuya Fukuoka, JP
3003244268	CRYO BIO SYSTEM	Saint Ouen sur Iton Orne, FR
3002465911	PLANER Limited	SUNBURY, MIDDLESEX England, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009747883. Last updated year: 2026. Please use registration number 3009747883 when referencing this establishment in official correspondence.