Unomedical A/S
Denmark DK-MF-000002447 Last updated 23 Oct 2026
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- Devices
- 29
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Comfort Ref 420470
AutoSoft90™ Ref 1014322
Contact Ref 420467
AutoSoft30™ Ref 1000283
Inset Guard Ref 510455
VariSoft™ Ref 1002830
AutoSoft90™ Ref 1000282
Comfort Ref 504475
AutoSoft90™ Ref 1000281
AutoSoft90™ Ref 1002823
AutoSoft90™ Ref 1002819
Inset Guard Ref 510456
Contact Ref 507276
Contact Ref 506138
Contact Ref 506136
Contact Ref 506155
Inset Guard Ref 510465
Inset Guard Ref 510462
Neria Multi Ref 507258
AutoSoft90™ Ref 1002820
VariSoft™ Ref 1002832
AutoSoft90™ Ref 1002824
AutoSoft30™ Ref 1002825
TruSteel™ Ref 1002836
VariSoft™ Ref 1002827
TruSteel™ Ref 1002833
AutoSoft90™ Ref 1002821
AutoSoft90™ Ref 1002817
TruSteel™ Ref 1002835
AutoSoft+™ Ref 1017112
AutoSoft+™ Ref 1017131
AutoSoft+™ Ref 1017132
AutoSoft+™ Ref 1017130
AutoSoft+™ Ref 1017134
AutoSoft+™ Ref 1017113
AutoSoft+™ Ref 1017129
AutoSoft+™ Ref 1017128
AutoSoft+™ Ref 1017127
AutoSoft+™ Ref 1017133
EUDAMED certificates
GMED SAS 0459 1 certificate
- 39124 Supplemented
Quality management system EU MDR
- Issued
- 4 Sep 2026
- Expires
- 30 Aug 2027
- Reason
- Add device or group
Related companies
Notified bodies
- GMED SAS 0459
What Unomedical A/S makes
Unomedical A/S manufactures the AutoSoft+™, a reusable, disposable-free infusion pump designed for intravenous therapy in hospital settings. The device is intended for administering fluids and medications at controlled rates, with features supporting patient-specific dosing and monitoring.
The AutoSoft+™ is classified as a Class IIb medical device under EU regulations and is listed in the EUDAMED database. The company is based in Denmark.
Frequently asked questions
What types of medical devices does Unomedical A/S manufacture?
Unomedical A/S specializes in infusion pumps, specifically the AutoSoft+™. This device is designed for intravenous therapy in hospitals, allowing controlled administration of fluids and medications without the need for disposable components. It is reusable and features patient-specific dosing and monitoring capabilities.
Where is Unomedical A/S based?
Unomedical A/S is headquartered in Denmark. The company’s location in Denmark aligns with its focus on developing infusion technology for hospital environments, particularly in Europe.
Which regulatory registries list Unomedical A/S’s devices?
Unomedical A/S’s devices, including the AutoSoft+™, are listed in the EUDAMED database. This registry is the official European Union database for medical devices, ensuring transparency and traceability of products authorized under EU regulations.
How are Unomedical A/S’s devices classified under EU regulations?
The AutoSoft+™ infusion pump manufactured by Unomedical A/S is classified as a Class IIb medical device under EU regulations. This classification is based on its intended use—administering intravenous fluids and medications in hospital settings—where it poses moderate risks requiring stringent design controls and conformity assessments.
Information
- Country
- Denmark
- Address
- 1-3, Aaholmvej , Lejre, Denmark
- Website
- convatec.com
- [email protected]
- Phone
- +45 31648365
- PRRC contact
- Rikke Eiland
- EUDAMED SRN
- DK-MF-000002447
- FDA FEI number
- 1000477110