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Miri Tl

FDA UDIEUDAMED

Class II (US FDA UDI)

by Esco Medical Technologies Uab

Identity

Trade Name
MIRI TL FDA UDI
Generic Name
Assisted reproduction incubator/microscope camera system FDA UDI
Device Name
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. FDA UDI
Model / Reference
MIRI TL FDA UDI
Description
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. FDA UDI

Identifiers

Primary DI / UDI-DI
04779041940113 FDA UDI
510(k) Number
K151357 FDA UDI
FDA Product Code
MQG FDA UDI
GMDN Term
Assisted reproduction incubator/microscope camera system 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Assisted reproduction incubator/microscope camera system

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Esco Medical Technologies Uab

Sources (2)

  • FDA UDI f2ea7fd4-6ec6-4a53-bcff-6c8426e8b193 34 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026