380 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Albomed GmbH
Manufacturer
🇩🇪 Germany·11 Basic UDI-DIs·11 Devices·HTCert (Health Technology Certification Ltd)
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 16, 2022
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Brainlab AG·June 16, 2021
MED-RAS GmbH Regulatory Affairs Service
Authorized representative
🇩🇪 Germany·18 Manufacturers·235 Devices
2385C04210501
Certificate
MDD Annex II (excluding section 4)·Albomed GmbH·HTCert (Health Technology Certification Ltd)·11 Basic UDI-DIs
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
·
Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Device
EU MDD
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Eu Md Class 3
·Albomed GmbH·On the market·27 countries
iTD GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
Strom Holdings UK Ltd
Authorized representative
🇩🇪 Germany
Hyaluronate Intra-Articular-Max Gel
Basic UDI-DI
EU MDD
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Eu Md Class 3
·Albomed GmbH·1 device
Hyaluronate Intra-Articular-Max Gel
Basic UDI-DI
EU MDD
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Eu Md Class 3
·Albomed GmbH·1 device