EU Manufacturer
๐ฉ๐ช Germany
Active
medentis medical GmbH
SRN: DE-MF-000007754
ยท
Walporzheimer Str. 48-52, 53474 Bad Neuenahr-Ahrweiler, Germany
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
2
Valid
1
Expiring < 6mo
0
Countries
29
Basic Information
- Address
- Walporzheimer Str. 48-52, 53474 Bad Neuenahr-Ahrweiler, Germany
- [email protected]
- Phone
- +49 2641 9110-0
- Website
- www.medentis.de
Regulatory Overview
Regulation
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Eu Mdd
1
Eu Mdr
1
Classification
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Eu Md Class 1
1
Eu Md Class 2a
1
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Expired / Withdrawn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) | HD 1753171-1 | TรV Rheinland LGA Products GmbH | May 25, 2024 | |||
| MDR QMS | HZ 1753171-1 | TรV Rheinland LGA Products GmbH | MDR | Aug 2023 | Aug 30, 2028 | Issued |
Market Presence
Devices from this manufacturer are available in 29 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ICX insertion tool ISO-shank | EU MDD | Eu Md Class 2a | On Market | 1 |
| ICX model analogue BL | EU MDR | Eu Md Class 1 | On Market | 0 |