Notified Body
NB 2962
🇦🇹 Austria
QMD Services GmbH
Zelinkagasse 10/3, 1010 Vienna, Austria
View on EUDAMED
Updated Dec 24, 2022
Certificates
6
Valid
4
Expiring < 6mo
0
Expired
0
Basic UDI-DIs
1
Devices
1
Manufacturers
3
Cert. Types
2
Basic Information
- Address
- Zelinkagasse 10/3, 1010 Vienna, Austria
- [email protected]
- Phone
- +43 1 533 0077
- Website
- https://www.qmdservices.com/
Regulatory Overview
Regulation
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Eu Ivdr
1
Classification
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Eu Ivd Class B
1
Device Types
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Certificate Health
Total
6
Valid
4
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDR QMS | IQMS/00001/0v002 | Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S. | IVDR | May 2024 | May 26, 2029 | Supplemented |
| IVDR Technical Documentation | ITDA/00002/0 v002 | GENSPEED Biotech | IVDR | Sep 2024 | Sep 04, 2029 | Issued |
| IVDR Technical Documentation | ITDA/00002/0 v001 | GENSPEED Biotech | IVDR | Sep 2024 | Sep 04, 2029 | Withdrawn |
| IVDR QMS | IQMS/00002/0v001 | GENSPEED Biotech | IVDR | Sep 2024 | Sep 04, 2029 | Issued |
| IVDR QMS | IQMS/00003/0 v002 | MacroArray Diagnostics | IVDR | Sep 2024 | Sep 17, 2029 | Supplemented |
| IVDR Technical Documentation | ITDA/00002/0 | GENSPEED Biotech | — |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| GENSPEED Biotech | 🇦🇹 Austria | 4 | 2 | 0 |
| Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S. | 🇹🇷 Türkiye | 1 | 1 | 0 |
| MacroArray Diagnostics | 🇦🇹 Austria | 1 | 1 | 0 |