EU Manufacturer
🇩🇪 Germany
Active
QualiMed Innovative Medizinprodukte GmbH
SRN: DE-MF-000008095
·
Boschstraße 16, 21423 Winsen (Luhe), Germany
Basic UDI-DIs
2224
Total Devices
2224
On Market
2224
Off Market
0
Certificates
23
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Boschstraße 16, 21423 Winsen (Luhe), Germany
- [email protected]
- Phone
- +49 4171 6578 171
- Website
- www.qualimed.de
Regulatory Overview
Regulation
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Eu Mdd
2224
Classification
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Eu Md Class 2b
908
Eu Md Class 2a
782
Eu Md Class 3
534
Device Types
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Certificate Health
Total
23
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
23
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | 50289-23-N5-1 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50289-23-N5 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50289-23-N5-4 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50289-23-N5-3 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 5028-23-N5-3 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50298-23-N5-3 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50289-23-N5-2 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50298-23-N5-1 | DEKRA Certification GmbH | Mar 30, 2023 | |||
| MDD Annex II Section 4 | 50289-23-Q3 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 50289-23-Q3-5 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 50289-23-Q3-2 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 50289-23-Q3-3 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 20589-23-Q3-3 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 20589-23-Q3-1 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 50289-23-Q3-1 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II Section 4 | 50289-23-Q3-1 | DEKRA Certification GmbH | Apr 02, 2023 | |||
| MDD Annex II (excluding section 4) | 50289-16-07 | DEKRA Certification GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 50289-16-07-5 | DEKRA Certification GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 50289-16-07-2 | DEKRA Certification GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 50289-16-07-3 | DEKRA Certification GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 50289-16-07-1 | DEKRA Certification GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 1434-MDD-229/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | 1434-MDD-230/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter (VX) | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| EMAX Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Guiding Sheath (GSQ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| ISOLV Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISOLV Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISOLV Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISOLV Aspiration Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| ISTAR PTCA Balloon Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |