EU Manufacturer
🇩🇪 Germany
Active
Advanced Medical Balloons GmbH
SRN: DE-MF-000008364
·
Bruchsaler Straße 22, 68753 Waghäusel, Germany
Basic UDI-DIs
4
Total Devices
7
On Market
7
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
8
Basic Information
- Address
- Bruchsaler Straße 22, 68753 Waghäusel, Germany
- [email protected]
- Phone
- +49 7254 40397-0
- Website
- www.amb-medtec.com
Regulatory Overview
Regulation
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Eu Mdd
2
Eu Mdr
2
Classification
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Eu Md Class 2a
3
Eu Md Class 1
1
Certificate Health
Total
1
Valid
0
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Expired / Withdrawn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) | D1479400002 | MDC MEDICAL DEVICE CERTIFICATION GMBH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 8 countries across Europe.
🇦🇹 Austria
🇩🇪 Germany
🇫🇮 Finland
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇵🇱 Poland
🇷🇴 Romania
🇸🇮 Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| hygh-tec bag | EU MDR | Eu Md Class 1 | On Market | 0 |
| hygh-tec bag | EU MDR | Eu Md Class 1 | On Market | 0 |
| hygh-tec basic plus | EU MDR | Eu Md Class 2a | On Market | 0 |
| hygh-tec basic-plus | EU MDD | Eu Md Class 2a | On Market | 1 |
| hygh-tec basic-plus | EU MDR | Eu Md Class 2a | On Market | 0 |
| hygh-tec basic-plus | EU MDD | Eu Md Class 2a | On Market | 1 |
| hygh-tec odor-solution | EU MDR | Eu Md Class 2a | On Market | 0 |