EmbryoAssist

FDA UDI

Class II (US FDA UDI)

by Origio A/S

Identity

Trade Name: EmbryoAssist FDA UDI
Generic Name: IVF medium FDA UDI
Device Name: EmbryoAssist with phenol red. 60 ml FDA UDI
Model / Reference: 12140060D FDA UDI
Description: EmbryoAssist with phenol red. 60 ml FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937801606 FDA UDI
FDA Product Code: MQL FDA UDI
GMDN Term: IVF medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF medium

EmbryoAssist by Origio A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Origio A/S

Sources (1)

FDA UDI d6ee6b08-3d05-4f6b-9cce-72dd72725846 34 fields · synced May 30, 2026