EU Manufacturer
๐บ๐ธ United States
Active
Align Technology Inc.
SRN: US-MF-000000744
ยท
2820 Orchard Parkway, CA 95134 San Jose, United States
Basic UDI-DIs
10
Total Devices
43
On Market
42
Off Market
1
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- 2820 Orchard Parkway, CA 95134 San Jose, United States
- [email protected]
- Website
- www.aligntech.com
Regulatory Overview
Regulation
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Eu Mdr
8
Eu Mdd
2
Classification
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Eu Md Class 1
6
Eu Md Class 2a
4
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 3823657CE01 | DEKRA Certification B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Invisalign Cheek Retractor, Medium | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Cleaning Crystals 250 pcs | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Cleaning Crystals 3 pcs | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Cleaning Crystals 50 pcs | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Cleaning System for Aligners and Retainers (with Tub) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Detail Pliers | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Eraser Pliers | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign First-Comprehensive | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign First-Moderate | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Full | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Go | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Go | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Go Express | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Go Plus | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Impression Tray, Plastic, Lower, Large | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Lower, Medium | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Lower, Small | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Lower, X-Large | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Upper, Large | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Upper, Medium | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Upper, Small | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Impression Tray, Plastic, Upper, X-Large | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign Lens | EU MDR | Eu Md Class 1 | Off Market | 0 |
| Invisalign Lite | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Palatal Expander | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Palatal Holder | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Pliers Set (Detail/Eraser) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign System | EU MDD | Eu Md Class 2a | On Market | 1 |
| Invisalign System - Comprehensive | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign System - Moderate | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign System - Teen Package | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign System โ Express | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign System โ Lite | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign System-Comprehensive Phase 2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Teen | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign Touch-up | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign i7 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Invisalign lens (Sm EU Core) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign lens (Sm EU Secondary) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign lens (Std EU Core) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Invisalign lens (Std EU Secondary) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Virtual Care 3.0 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Vivera Retainer | EU MDD | Eu Md Class 2a | On Market | 1 |