Authorized Representative
🇩🇪 Germany
Active
MedDevConsult GmbH
SRN: DE-AR-000005877
·
Flughafenstrasse 52a, 22335 Hamburg, Germany
Manufacturers
8
Devices
14
Certificates
1
PRRCs
1
Basic Information
- Address
- Flughafenstrasse 52a, 22335 Hamburg, Germany
- [email protected]
- VAT Number
- DE 32892745
- Trade Register
- HRB 160330
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| CapsoVision, Inc. | 🇺🇸 United States | US-MF-000008446 |
| Fuji Systems Corporation | 🇯🇵 Japan | JP-MF-000006591 |
| Acotec Scientific Co., Ltd | 🇨🇳 China | CN-MF-000015843 |
| VascuPatent Medical (Shenzhen) Co., Ltd | 🇨🇳 China | CN-MF-000025358 |
| Uptake Medical Technologies, Inc. | 🇺🇸 United States | US-MF-000032755 |
| Lorem Cytori USA, Inc. | 🇺🇸 United States | US-MF-000035412 |
| Nuwellis, Inc. | 🇺🇸 United States | US-MF-000028224 |
| Broncus Medical, Inc. | 🇺🇸 United States | US-MF-000027543 |
Manufacturers
Nuwellis, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Broncus Medical, Inc.
Manufacturer
🇺🇸 United States·10 Basic UDI-DIs·10 Devices·4 Importers·BSI Group The Netherlands B.V.
CapsoVision, Inc.
Manufacturer
🇺🇸 United States·4 Basic UDI-DIs·4 Devices
Fuji Systems Corporation
Manufacturer
🇯🇵 Japan·8 Importers
VascuPatent Medical (Shenzhen) Co., Ltd
Manufacturer
🇨🇳 China
Uptake Medical Technologies, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Acotec Scientific Co., Ltd
Manufacturer
🇨🇳 China·3 Importers
Lorem Cytori USA, Inc.
Manufacturer
🇺🇸 United States
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 562232 | Broncus Medical, Inc. | BSI Group The Netherlands B.V. | Expired |
Devices
EasyPath® RF Introducer Sheath
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes® System
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes® Lite
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes® System
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes® System
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes Access Kit
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes Dilation Balloon
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
Archimedes Sheath
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
FleXNeedle® Transbronchial Aspiration Needle
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
FleXNeedle® Transbronchial Aspiration Needle
Device
EU MDD
·
Eu Md Class 2a
·Broncus Medical, Inc.·On the market·32 countries
CapsoCloud
Device
EU MDR
·
Eu Md Class 1
·CapsoVision, Inc.·On the market·32 countries
CapsoView
Device
EU MDR
·
Eu Md Class 2a
·CapsoVision, Inc.·On the market·32 countries
CapsoAccess
Device
EU MDR
·
Eu Md Class 1
·CapsoVision, Inc.·On the market·32 countries
GASTROINTESTINAL IMAGING DIAGNOSTIC DEVICES
Device
EU MDR
·
Eu Md Class 2a
·CapsoVision, Inc.·On the market·32 countries