EU Manufacturer
๐บ๐ธ United States
Active
LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803
SRN: US-MF-000016778
ยท
Second Avenue 63, 01803 Burlington, Massachusetts, United States
Basic UDI-DIs
7
Total Devices
10
On Market
10
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Second Avenue 63, 01803 Burlington, Massachusetts, United States
- [email protected]
- Phone
- +1 781-425-1735
- Website
- www.lemaitre.com
Regulatory Overview
Regulation
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Eu Mdd
4
Eu Mdr
3
Classification
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Eu Md Class 3
4
Eu Md Class 2a
3
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | G7AO 060725 0019 | TรV SรD Product Service GmbH | Dec 31, 2027 | |||
| MDD Annex II Section 4 | G7AP 060725 0019 | TรV SรD Product Service GmbH | Dec 31, 2027 |
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 | ||||
|---|---|---|---|---|
| Eze-Sitยฎ Valvulotome | EU MDR | Eu Md Class 2a | On Market | 0 |
| LeMaitre Valvulotome | EU MDR | Eu Md Class 2a | On Market | 0 |
| LeMaitreยฎ Valvulotome | EU MDR | Eu Md Class 2a | On Market | 0 |
| PERICARDIUM VASCULAR PATCHES | EU MDD | Eu Md Class 3 | On Market | 1 |
| VALVULOTOMES, SINGLE-USE | EU MDR | Eu Md Class 2a | On Market | 0 |
| VALVULOTOMES, SINGLE-USE | EU MDR | Eu Md Class 2a | On Market | 0 |
| VALVULOTOMES, SINGLE-USE | EU MDR | Eu Md Class 2a | On Market | 0 |
| XenoSureยฎ | EU MDD | Eu Md Class 3 | On Market | 1 |
| XenoSureยฎ Biologic Patch | EU MDD | Eu Md Class 3 | On Market | 1 |
| XenoSureยฎ Biologic Patch | EU MDD | Eu Md Class 3 | On Market | 1 |