Neurescue Aps
Active in EUDAMEDDenmarkfrom SRN EUDAMED SRN DK-MF-000010162
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Neurescue Aps makes
Neurescue Aps manufactures a medical device designed for neurological resuscitation and monitoring, intended to support critical care interventions in acute neurological emergencies.
The company’s portfolio is regulated under FDA’s Class II designation, with devices authorised via the 510(k) pathway. The products are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
NEURESCUE Device Ref 400999-00
Regimes: CE MDR Registry: EUDAMEDNEURESCUE device Ref 400009-00
Regimes: CE MDR Registry: EUDAMEDNeurescue device Ref K210358
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- DK-MF-000010162
- EU VAT number
- CVRP-nr 1019215055
- EUDAMED status
- Active
- EUDAMED registered name
- Neurescue Aps
- Registered address
- 11, Antonigade, 1106, Copenhagen, Denmark
- Website
- www.neurescue.com
- [email protected]
- Phone
- +45 5 353 67 60
- PRRC contact
- Malin Hansson
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 11 Aug 2030
TÜV SÜD Danmark 2443 2 certificates
- G11DK 133591 0001 Active
Quality management system EU MDR
- Issued
- 12 Aug 2025
- Expires
- 11 Aug 2030
- G70DK 133591 0002 Active
Technical documentation EU MDR
- Issued
- 12 Aug 2025
- Expires
- 11 Aug 2030
Frequently asked questions
How many devices does Neurescue Aps have in the registry?
The registry currently lists 3 devices for Neurescue Aps. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neurescue Aps's devices?
Among its 3 most recently registered devices, Neurescue Aps has devices listed in EUDAMED (2 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neurescue Aps's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Neurescue Aps's devices are Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Neurescue Aps?
EUDAMED lists 2 certificates for Neurescue Aps (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 12 Aug 2025.
What are the newest devices from Neurescue Aps in the registry?
The most recently registered devices listed for Neurescue Aps include NEURESCUE Device.