Authorized Representative
🇳🇱 Netherlands
Active
Align Technology B.V.
SRN: NL-AR-000000061
·
Herikerbergweg 312, 1101CT Amsterdam, Netherlands
Manufacturers
3
Devices
95
Certificates
1
PRRCs
2
Basic Information
- Address
- Herikerbergweg 312, 1101CT Amsterdam, Netherlands
- [email protected]
- Website
- www.aligntech.com
- Trade Register
- 34207531
- EORI
- NL813177376
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Align Technology (Sichuan) Medical Equipment Co.,Ltd. | 🇨🇳 China | CN-MF-000024868 |
| Align Technology Inc. | 🇺🇸 United States | US-MF-000000744 |
| Align Technology Ltd. | 🇮🇱 Israel | IL-MF-000000745 |
Manufacturers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 3823657CE01 | Align Technology Inc. | DEKRA Certification B.V. | Expired |
Devices
iTero Lumina Pro Software
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Pro Scanning Unit, RMA Package
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Pro Scanning Unit, RMA Package
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Pro Scanning Unit, RMA
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Pro intraoral scanning unit
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element Scanner Sleeve
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element Scanner Sleeve
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanner Sleeve
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
Packed Panel PC ASSY, 5D iTero Element, RMA
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element™ 5D Plus DOA service kit
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D DOA Kit
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D scanning unit, RMA
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element™ 5D Plus
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Laptop Configuration
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Rental
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
E5D Plus Scanning Unit
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Plus Mobile Configuration
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Plus
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Laptop Configuration Upgrade Kit
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Upgrade Kit
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D Laptop Configuration
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Element 5D
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanning Unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanning Unit RMA
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Mobile Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Scanning Unit Lumina
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanning Unit RMA Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanning Unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanning Unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Scanning Unit RMA Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market
iTero Lumina Mobile Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina DOA Kit, cart
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Mobile Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Cart Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Mobile upgrade from Element Plus
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Cart upgrade from Element Plus
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Lumina Cart Configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Plus Mobile Computing unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Plus Mobile Computing unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Plus Mobile Computing Unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Plus Computing unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Plus Computing unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Plus Computing unit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element Plus Wheel Stand, kit
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Wheel Stand
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element 2 Plus
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element 2 Plus
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element 2 Plus Mobile configuration
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element Flex
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element Flex
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element 2
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
iTero Element 2
Device
EU MDR
·
Eu Md Class 1
·Align Technology Ltd.·On the market·32 countries
Invisalign System - Teen Package
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Touch-up
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Go Express
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Go
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Go Plus
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign First-Comprehensive
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign System-Comprehensive Phase 2
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign System – Express
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign First-Moderate
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign System – Lite
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign System - Moderate
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign System - Comprehensive
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Go
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Lite
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign i7
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Teen
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Full
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Palatal Expander
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Palatal Holder
Device
EU MDR
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Lens
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·No longer on the market·32 countries
Invisalign lens (Sm EU Secondary)
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign lens (Std EU Secondary)
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign lens (Sm EU Core)
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign lens (Std EU Core)
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Vivera Retainer
Device
EU MDD
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Cleaning System for Aligners and Retainers (with Tub)
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Cleaning Crystals 50 pcs
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Cleaning Crystals 250 pcs
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Cleaning Crystals 3 pcs
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Virtual Care 3.0
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Pliers Set (Detail/Eraser)
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Eraser Pliers
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Detail Pliers
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Cheek Retractor, Medium
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign System
Device
EU MDD
·
Eu Md Class 2a
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Upper, Small
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Lower, Small
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Upper, Medium
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Upper, Large
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Lower, Medium
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Upper, X-Large
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Lower, X-Large
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries
Invisalign Impression Tray, Plastic, Lower, Large
Device
EU MDR
·
Eu Md Class 1
·Align Technology Inc.·On the market·32 countries