VYGON Germany GmbH
Germany DE-MF-000005305 Last updated 23 Oct 2026
- Devices
- 410
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
multicath3 Ref 1231.122
dualysecathexpert Ref 8132.90
multicath3 Ref 155.530
seldipur smartmidline Ref 128.14202
multicath4 Ref 158.052
premicath Ref 1261.22
repairset lifecath Ref 2194.27
Stiletto™ Ref 1214.1812
dualysecath Ref 1132.81
multicath5expert Ref 8159.207
trilysecathexpert Ref 8139.511
trilysecathexpert Ref 8139.210
multicath7 UP Ref 170.172
Desivalve Ref 1149.05
dualysecath Ref 1132.91
multistar2 Ref 6203.083
dualysecathexpert Ref 8132.010
multicath3 Ref 155.352
multicath3 Ref 1233.062
trilysecathexpert Ref 8139.215
trilysecath Ref 1139.51
multistar4 UP Ref 6158.072
multicath2 Ref 1203.082
umbilicalcath2 expert Ref 8272.540
epicutaneo2 Ref 2484.302
trilysecath Ref 1139.52
seldipur smartmidline Ref 128.1310
multistar4 UP Ref 6158.172
maxfloexpert Ref 8394.405
bipacingball Ref 1144.05
maxfloexpert Ref 8394.526
premistar Ref 6261.203
introducath desilet "break away" Ref 1146.08
lifecath triple Ref 2294.125
multicath4 Ref 158.252
Desivalve Ref 1149.17
lifecath PICC easy Ref 1295.115
trilysecath Ref 1139.220
multicath2 Ref 157.052
epicutaneo cava Ref 2184.030
introducath desilet "break away" Ref 1146.14
introducath desilet "break away" Ref 1146.10
trilysecathexpert Ref 8139.220
dualysecathexpert Ref 8132.110
lifecath midline pur Ref 1296.114
multicath5expert Ref 8159.252
lifecath biflux Ref 2293.11
nutriline Ref 1352.152
premicath Ref 1261.206
maxfloexpert Ref 8394.506
Showing 1-50 of 410
EUDAMED certificates
Notified body 2797 1 certificate
- MDR 817414 Supplemented
Quality management system EU MDR
- Issued
- 21 Sep 2026
- Expires
- 29 Jun 2030
- Reason
- Change approved
Related companies
Notified bodies
- Notified body 2797
About
Qualitative, innovative medical devices - Vygon is your partner for medical technology & safe medical devices
What VYGON Germany GmbH makes
VYGON Germany GmbH manufactures central venous catheterization kits for short-term use, including products such as splitneedle, premistar, multicath3, leadercathexpert, multicath2, multicath2expert UP, and multicath5expert.
These devices are classified as Class III and Class IIa and are listed in the EUDAMED registry. The company is based in Germany.
Frequently asked questions
What types of medical devices does VYGON Germany GmbH manufacture?
VYGON Germany GmbH produces central venous catheterization kits intended for short‑term use. The product line includes items such as splitneedle, premistar, multicath3, leadercathexpert, multicath2, multicath2expert UP, and multicath5expert, all of which fall under the central venous catheter category.
Where is VYGON Germany GmbH located and which regulatory registry lists its devices?
The company is based in Germany, as indicated by the country code DE. All of its central venous catheter kits are listed in the European Union’s EUDAMED database, which is the official registry for medical devices marketed in the EU.
How are VYGON’s central venous catheter kits classified under EU medical device rules?
The devices are assigned to two risk classes: some kits are classified as Class III, reflecting the highest level of risk and regulatory scrutiny, while others fall under Class IIa, indicating a moderate risk level. This classification is based on the intended use and duration of catheterization.
Why might a healthcare provider need to know the device class of VYGON’s products?
Knowing the device class informs the provider about the regulatory requirements each product has met, such as conformity assessment procedures and clinical evaluation depth. Class III devices undergo the most rigorous assessment, which can affect procurement decisions, usage protocols, and post‑market surveillance obligations.
Information
- Country
- Germany
- Address
- 100, Prager Ring, Aachen, Germany
- Website
- www.vygon.de
- facebook.com/VygonDeutschland
- [email protected]
- Phone
- +4924191300
- PRRC contact
- Bernd Marx
- EUDAMED SRN
- DE-MF-000005305
- FDA FEI number
- 3002808464