EU Manufacturer
๐บ๐ธ United States
Active
Cutera, Inc.
SRN: US-MF-000010456
ยท
Bayshore Blvd 3240, 94005 Brisbane, United States
Basic UDI-DIs
17
Total Devices
21
On Market
21
Off Market
0
Certificates
2
Valid
1
Expiring < 6mo
0
Countries
17
Basic Information
- Address
- Bayshore Blvd 3240, 94005 Brisbane, United States
- [email protected]
- Phone
- +1 415-657-5500
- Website
- www.cutera.com
Regulatory Overview
Regulation
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Eu Mdd
16
Eu Mdr
1
Classification
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Eu Md Class 2b
17
Device Types
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Certificate Health
Total
2
Valid
1
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Expired / Withdrawn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) | 44232117851 | TรV NORD CERT GmbH | Apr 15, 2023 | |||
| MDR QMS | TNP/MDR/0029/5488/2025 | TUV NORD Polska Sp. z o.o | MDR | Jan 2025 | Jan 12, 2030 | Issued |
Market Presence
Devices from this manufacturer are available in 17 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AcuTip 500 | EU MDD | Eu Md Class 2b | On Market | 1 |
| Acutip | EU MDR | Eu Md Class 2b | On Market | 0 |
| AviClear | EU MDD | Eu Md Class 2b | On Market | 1 |
| Limelight | EU MDR | Eu Md Class 2b | On Market | 0 |
| Limelight | EU MDD | Eu Md Class 2b | On Market | 1 |
| Pearl Fractional | EU MDD | Eu Md Class 2b | On Market | 1 |
| ProWave LX | EU MDD | Eu Md Class 2b | On Market | 1 |
| Prowave | EU MDR | Eu Md Class 2b | On Market | 0 |
| Titan XL | EU MDD | Eu Md Class 2b | On Market | 1 |
| enlighten III | EU MDD | Eu Md Class 2b | On Market | 1 |
| enlighten SR | EU MDD | Eu Md Class 2b | On Market | 1 |
| excel HR | EU MDD | Eu Md Class 2b | On Market | 1 |
| excel V+ | EU MDD | Eu Md Class 2b | On Market | 1 |
| truSculpt 16 | EU MDD | Eu Md Class 2b | On Market | 1 |
| truSculpt 40 HF | EU MDD | Eu Md Class 2b | On Market | 1 |
| truSculpt 40 HH | EU MDD | Eu Md Class 2b | On Market | 1 |
| truSculpt iD | EU MDD | Eu Md Class 2b | On Market | 1 |
| xeo | EU MDD | Eu Md Class 2b | On Market | 1 |
| xeo SA | EU MDD | Eu Md Class 2b | On Market | 1 |
| xeo+ | EU MDR | Eu Md Class 2b | On Market | 0 |
| xeo+ SA | EU MDR | Eu Md Class 2b | On Market | 0 |