Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008650534

FEI Number

3008650534

Entity Name

HALOTECH DNA

City/State/Country

MADRID, ES

Establishment Address

C/FARADAY 7, 1.08, MADRID 28049, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Halotech DNA (Owner Number: 10089385)

Owner / Operator Contact Address

C/FARADAY 7, 1.08, MADRID, ES-MD 28049, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Halosperm G2 DNA fragmentation kit ovoselect DNA fragmentation kit Halosperm DNA fragmentation kit dyn-halosperm DNA fragmentation kit Halosperm G2 PRO DNA fragmentation kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2023-12-04

Official Correspondent

Pablo Revilla

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

Halotech DNA

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008650534. Last updated year: 2026. Please use registration number 3008650534 when referencing this establishment in official correspondence.