← Back to catalogue

Vit Kit - Freeze NX

EUDAMEDFDA UDI

Class III (EU MDR)

Ref 90133-DSOCRef 90188

by Irvine Scientific, LLC.

Identity

Trade Name
Vit Kit - Freeze NX EUDAMED
Vit Kit - Freeze NX with Gentamicin and DSS FDA UDI
Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS FDA UDI
Generic Name
IVF medium FDA UDI
Device Name
Vitrification Freeze Kit (Vit Kit - Freeze) EUDAMED
Vit Kit - Freeze NX EUDAMED
Vit Kit - Freeze NX (Vitrification Kit for Freezing) with Gentamicin and DSS. Includes 3x1mL Equilibration NX-ES (white cap), 3x1mL Vitrification NX-VS (blue cap), 1x1mL Washing NX-WS (red cap) FDA UDI
Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 9x1mL Vials Equilibration Solution - ES (white cap) and 9x1mL Vials Vitrification Solution - VS (blue cap). FDA UDI
Model / Reference
90133-DSOC EUDAMEDFDA UDI
90188 EUDAMEDFDA UDI
Description
Vit Kit - Freeze NX (Vitrification Kit for Freezing) with Gentamicin and DSS. Includes 3x1mL Equilibration NX-ES (white cap), 3x1mL Vitrification NX-VS (blue cap), 1x1mL Washing NX-WS (red cap) FDA UDI
Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 9x1mL Vials Equilibration Solution - ES (white cap) and 9x1mL Vials Vitrification Solution - VS (blue cap). FDA UDI

Identifiers

Catalog Number
90188 FDA UDI
90133-DSOC FDA UDI
Primary DI / UDI-DI
00810195240323 EUDAMEDFDA UDI
00810195240309 EUDAMEDFDA UDI
Basic UDI-DI
B-00810195240323 EUDAMED
B-00810195240309 EUDAMED
FDA Product Code
MQL FDA UDI
EMDN Code
U08020501 MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION EUDAMED
GMDN Term
IVF medium FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
884.6180 FDA UDI
Market of Registration
Netherlands EUDAMED
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

Yes

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

Yes

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Vit Kit - Freeze NX by Irvine Scientific, Llc — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Irvine Scientific, LLC.
EUDAMED SRN
US-MF-000007514
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (6)

  • EUDAMED 8936f6ea-9506-4ed2-b045-40e28283a110 61 fields · synced Jul 24, 2026
  • EUDAMED 89d01557-c290-4fff-a31f-4e5533ea0bc2 61 fields · synced May 17, 2026
  • FDA UDI 748734f5-b3ac-4575-926f-b6af92471b8f 34 fields · synced May 26, 2026
  • FDA UDI cf6d5289-a9b8-43ba-a1b9-45e94b2423f9 35 fields · synced May 30, 2026
  • EUDAMED b6c0f1f8-90ad-4ba7-9d7d-43d431102cb3 61 fields · synced Jul 10, 2026
  • EUDAMED bc332381-8358-4559-a9de-03e608ff8ef8 61 fields · synced Jul 24, 2026