Miri

FDA UDI

Class II (US FDA UDI)

by Esco Medical Technologies Uab

Identity

Trade Name: MIRI FDA UDI
Generic Name: Assisted reproduction heater/incubator FDA UDI
Device Name: The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blastocysts. FDA UDI
Model / Reference: MIRI FDA UDI
Description: The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blastocysts. FDA UDI

Identifiers

Primary DI / UDI-DI: 04779041940106 FDA UDI
510(k) Number: K133742 FDA UDI
FDA Product Code: MQG FDA UDI
GMDN Term: Assisted reproduction heater/incubator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Assisted reproduction heater/incubator

Miri by Esco Medical Technologies Uab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Assisted reproduction heater/incubator.

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Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC · Class II
Dry Incubator — ASTEC CO., LTD. · Class II
Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC · Class II
K-Systems — Research Instruments , Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Esco Medical Technologies Uab

Sources (1)

FDA UDI aa48df9a-8ead-4262-a035-c9533f8187f6 34 fields · synced Jun 8, 2026