Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1218813

FEI Number

1218813

Entity Name

MIRA, INC.

City/State/Country

UXBRIDGE, MA, US

Establishment Address

414 Quaker Hwy, UXBRIDGE, MA 01569, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MIRA, INC. (Owner Number: 1218813)

Owner / Operator Contact Address

414 QUAKER HIGHWAY, --, Uxbridge, MA 01569, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K760686

PMA Number

N/A

All Registered Proprietary Names

CR4095 IMEX Scleral Buckling Device, Ophthalmic CR4085 CR4015 CR4045 CR4023 CR4025 CR4080 CR4090 CR4040 CR4075 CR4000 CR4030 CR4010 CR4022

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPS	Unit, Cryophthalmic	Ophthalmic	Class 2	886.4170	2007-11-03
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2007-11-03
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2007-11-03

Official Correspondent

Charles Schepens

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MIRA, INC.

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
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218813. Last updated year: 2026. Please use registration number 1218813 when referencing this establishment in official correspondence.