EU Manufacturer
๐ธ๐ช Sweden
Active
PulseLavage AB
SRN: SE-MF-000002363
ยท
Rubanksgatan 8, SE-741 71 Knivsta, Sweden
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
3
Valid
2
Expiring < 6mo
0
Countries
10
Basic Information
- Address
- Rubanksgatan 8, SE-741 71 Knivsta, Sweden
- [email protected]
- Website
- www.pulselavage.se
Regulatory Overview
Regulation
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Eu Mdd
4
Eu Mdr
1
Classification
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Eu Md Class 2a
4
Eu Md Class 3
1
Certificate Health
Total
3
Valid
2
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | C-01-1196-749-20 | Eurofins Electric & Electronics Finland Oy | May 05, 2022 | |||
| MDR QMS | M.2023.MDR.1013 | UDEM Adriatic d.o.o. | MDR | Apr 2023 | Apr 05, 2027 | |
| MDR QA | M.2023.1014 | UDEM Adriatic d.o.o. | MDR | Apr 2023 | Apr 05, 2028 |
Market Presence
Devices from this manufacturer are available in 10 countries across Europe.
๐ฆ๐น Austria
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐ป Latvia
๐ณ๐ด Norway
๐ธ๐ช Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| GreenPulse | EU MDD | Eu Md Class 3 | On Market | 1 |
| GreenPulse Hip Set | EU MDR | Eu Md Class 2a | On Market | 0 |
| OrthoLavage | EU MDD | Eu Md Class 2a | On Market | 1 |
| RetraLight | EU MDD | Eu Md Class 2a | On Market | 1 |
| RetraLight | EU MDD | Eu Md Class 2a | On Market | 1 |