EU Manufacturer
🇩🇪 Germany
Active
Albutec GmbH
SRN: DE-MF-000009769
·
Schillingallee 68, 18057 Rostock, Germany
Basic UDI-DIs
13
Total Devices
20
On Market
13
Off Market
7
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Schillingallee 68, 18057 Rostock, Germany
- [email protected]
- Phone
- +4938112165875
- Website
- www.albutec.de
Regulatory Overview
Regulation
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Eu Mdd
12
Eu Mdr
1
Classification
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Eu Md Class 2a
12
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Expired / Withdrawn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) | 170769583 | DQS Medizinprodukte GmbH | May 25, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Hepalbin-Adsorber | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin-Cluster12 | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin-MaxiCycler1 deAir | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin-MaxiCycler3 deAir | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin-MaxiCycler5 deAir | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin-MaxiCycler7 deAir | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin-MaxiCycler9 deAir | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Hepalbin®-MaxiCycler1 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Hepalbin®-MaxiCycler3 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Hepalbin®-MaxiCycler5 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Hepalbin®-MaxiCycler7 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Hepalbin®-MaxiCycler9 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Holder For Dialyzers | EU MDR | Eu Md Class 1 | On Market | 0 |
| Holder For MC1 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Holder For MC3-9 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Holder I For Dialyzer | EU MDR | Eu Md Class 1 | On Market | 0 |
| Holder I For Infusion Pump | EU MDR | Eu Md Class 1 | On Market | 0 |
| Holder I For MC3-9 | EU MDR | Eu Md Class 1 | On Market | 0 |
| MC Hanger (Single Use) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Waste Bag Hanger | EU MDR | Eu Md Class 1 | On Market | 0 |