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Irvine Scientific, LLC. — Manufacturer in United States

EUDAMED update: Feb 4, 2026

IS

Irvine Scientific, LLC.

United States

All roles followed

Views by role

Sources: EUDAMED

Legal information of IS LLC

Legal name: Irvine Scientific, LLC.
EU VAT number: Not applicable
SRN (displayed role): US-MF-000007514
EUDAMED status: Active· registered in 2021
Registered office: E Warner Ave, 1830 92705 Santa Ana, United States

Contact details for IS LLC

Email: irvinesciRA@nexpringhealth.com
Address: 1830, E WARNER AVE 92705 SANTA ANA UNITED STATES

Data export

Export the 37 devices of IS LLC

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Medical device manufacturers in EUDAMED

Competent authority for IS LLC

Ministerie van Volksgezondheid, Welzijn en Sport
NetherlandsContact the authority →

Certificates of IS LLC

37Total Devices

37Basic UDI-DIs

1Certificates1 valid · 0 expiring < 12 months

32CountriesEU/EEA placements

Market presence of IS LLC

Devices placed in 32 countries

Risk categories of IS LLC

Executives & regulatory representatives of IS LLC

2 contacts identified

LAHADERNE Robert
PRRC
View profile →
LAHADERNE Robert
Hidden

Cartography of IS LLC

Authorised representativeNotified bodiesPeople

BSI Group The Netherlands B.V. — 1 certificate — IS LLC
Emergo Europe B.V. — represents — IS LLC
LAHADERNE Robert — IS LLC

Related documents of IS LLC

Technical documentation

Certificate MDR 835884Rev. R000

Issued

Manufacturer

Irvine Scientific, LLC.

Notified body

BSI Group The Netherlands B.V.

2797

Version

1

Valid from

8/25/2026

Valid until

8/24/2031

User manual

Auto-sourced from EUDAMED

Manufacturer

IS LLC

Language

English

User manual

Auto-sourced from EUDAMED

Manufacturer

IS LLC

Language

English

Catalog of IS LLC

37 devices · 37 families

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Oil for Embryo Culture9305-100mL1 version
Human Serum Albumin 9988-12x5mL1 version
Vit Kit - Warm NX901831 version
Vit Kit - Freeze NX901881 version
Vitrification Freeze Kit (Vit Kit - Freeze)90133-SO1 version
Vitrification Thaw Kit (Vit Kit - Thaw)90137-SO1 version
Vitrification Thaw Kit (Vit Kit - Thaw)90137-DSOC1 version
Vitrification Freeze Kit (Vit Kit - Freeze)90133-DSOC1 version
Multipurpose Handling Medium-Complete (MHM-C)90166-100mL1 version
Multipurpose Handling Medium-Complete (MHM-C)90166-500mL1 version
Multipurpose Handling Medium-Complete (MHM-C)90166-12x12mL1 version
Continuous Single Culture - NX Complete (CSCM-NXC)90168-60mL1 version
Continuous Single Culture - NX Complete (CSCM-NXC)90168-2x20mL1 version
Continuous Single Culture Complete (CSCM-C)90165-2x20mL1 version
ISolate Ready to Use Density Gradient Medium at Two Concentrations99264-12x6mL1 version
ISolate Ready to Use Density Gradient Medium at Two Concentrations99264-2x100mL1 version
ISolate Stock Solution99275-100mL1 version
Modified HTF Medium - HEPES with Gentamicin90126-100mL1 version
Modified HTF Medium-HEPES with Gentamicin90126-500mL1 version
Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20x5mL1 version
Multipurpose Handling Medium (MHM) with Gentamicin90163-100mL1 version
Multipurpose Handling Medium (MHM) with Gentamicin90163-500mL1 version
Continuous Single Culture (CSCM) with Gentamicin90164-60mL1 version
Continuous Single Culture - NX (CSCM-NX) with Gentamicin90167-60mL1 version
Hyaluronidase Solution90101-5x1mL1 version

37 families

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Browse all 37 products