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Origio Handling

FDA UDI

Class II (US FDA UDI)

by Origio A/S

Identity

Trade Name
Origio Handling FDA UDI
Generic Name
IVF medium FDA UDI
Device Name
Handling media 60 ml FDA UDI
Model / Reference
83100060D FDA UDI
Description
Handling media 60 ml FDA UDI

Identifiers

Catalog Number
8310 FDA UDI
Primary DI / UDI-DI
00888937835458 FDA UDI
510(k) Number
K173624 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: IVF medium

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

Similar devices

Also classified as IVF medium.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Origio A/S

Sources (1)

  • FDA UDI 633df1b2-3ed5-44ac-b886-44f5c81e67eb 36 fields · synced Jun 8, 2026