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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Active filter:Manufacturer SRN:IL-MF-000000745

86 device results listed.

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Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063023760
Basic UDI-DI: 081606302GUMSW66
Reference: 226797
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Software

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063023197
Basic UDI-DI: 081606302LMNSW6A
Reference: 225969
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Interface Box

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063023166
Basic UDI-DI: 081606302LMNIFB57
Reference: 223060
EMDN: Z12119085
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Pro Software

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063023067
Basic UDI-DI: 081606302SWPROAL
Reference: 225979
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina - PC cfg intraoral scanning unit

iTero Lumina PC cfg Intraoral Scanning Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063023050
Basic UDI-DI: 081606302LMNSCNUEV
Reference: 223102
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Pro intraoral scanning unit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063022190
Basic UDI-DI: 081606302IOCPRO5A
Reference: 221909
EMDN: Q010207
EMDN description: DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Scanner Sleeve

Class IMDR 2017/745On the marketSingle use

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063021483
Basic UDI-DI: 081606302LMNSLV8K
Reference: 215470
EMDN: Z12119085
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Cart Configuration

iTero Lumina System

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063021414
Basic UDI-DI: 081606302LMNSYS9L
Reference: 213782
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element Scanner Sleeve

iTero Element Scanner Sleeves

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020585
Basic UDI-DI: 081606302SLEEVE6S
Reference: 109236
EMDN: Z12119085
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 5D

iTero Element 5D Family

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020493
Basic UDI-DI: 081606302DISBH
Reference: 205929
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 2

iTero Element 2 family

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020288
Basic UDI-DI: 081606302ELEMENT6L
Reference: 202965
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Plus Mobile Computing Unit

iTero Plus Series Platform, Accessories for iTero Scanners

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020844
Basic UDI-DI: 0081606302PlusMCU5U
Reference: 211386
EMDN: Q010280
EMDN description: PROSTHETIC DENTISTRY DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Plus Computing unit

iTero Plus Series Platform, Accessories for iTero Scanners

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020837
Basic UDI-DI: 0081606302PlusCUKH
Reference: 211385
EMDN: Q010280
EMDN description: PROSTHETIC DENTISTRY DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Wheel Stand

Itero Wheel Stand

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020820
Basic UDI-DI: 0081606302WS7C
Reference: 211384
EMDN: Q010280
EMDN description: PROSTHETIC DENTISTRY DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element Flex

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020295
Basic UDI-DI: 081606302ELEMENT6L
Reference: 202964
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: Align Technology B.V.
Last updated: 09.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 5D Laptop Configuration

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020509
Basic UDI-DI: 081606302DISBH
Reference: 206160
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: Align Technology B.V.
Last updated: 23.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 5D Upgrade Kit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020561
Basic UDI-DI: 081606302DISBH
Reference: 206855
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: Align Technology B.V.
Last updated: 23.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 5D Laptop Configuration Upgrade Kit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020578
Basic UDI-DI: 081606302DISBH
Reference: 206856
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: Align Technology B.V.
Last updated: 23.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 2 Plus

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020684
Basic UDI-DI: 081606302ELEMENT6L
Reference: 211483
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: Align Technology B.V.
Last updated: 23.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 5D Plus

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020691
Basic UDI-DI: 081606302DISBH
Reference: 211484
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: Align Technology B.V.
Last updated: 23.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details