EU Manufacturer
๐บ๐ธ United States
Active
BIOLASE MG LLC
SRN: US-MF-000028587
ยท
Towne Centre Drive 27042, 92610 Foothill Ranch, United States
Basic UDI-DIs
185
Total Devices
185
On Market
185
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Towne Centre Drive 27042, 92610 Foothill Ranch, United States
- [email protected]
- Website
- https://www.biolase.com/
Regulatory Overview
Regulation
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Eu Mdd
185
Classification
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Eu Md Class 2a
136
Eu Md Class 2b
40
Eu Md Class 1
9
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 4652GB410210517A | DNV MEDCERT GmbH | Jun 08, 2023 | |||
| MDD Annex II (excluding section 4) | 4652GB410210517A | DNV MEDCERT GmbH | Jun 08, 2023 |
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 | ||||
|---|---|---|---|---|
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Epic Hygiene Diode Laser System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Laser Handpiece | EU MDD | Eu Md Class 1 | On Market | 1 |
| Laser Handpiece | EU MDD | Eu Md Class 1 | On Market | 1 |
| Laser Handpiece | EU MDD | Eu Md Class 1 | On Market | 1 |
| Waterlase Laser Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Quartz | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Sapphire | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Sapphire | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Sapphire | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Sapphire | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase Laser Tips - Sapphire | EU MDD | Eu Md Class 2a | On Market | 1 |
| Waterlase iPlus Laser System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Waterlase iPlus Laser System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Waterlase iPlus Laser System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Non Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |
| Diode Laser Tips - Pre Initiated Tips | EU MDD | Eu Md Class 2a | On Market | 1 |