SP Medical A/S
Active in EUDAMEDDenmarkfrom SRN EUDAMED SRN DK-MF-000019782
- Devices
- 843
- Registrations
- EUDAMED
At a glance
EU certificates
5 of 5 in force.
Market reach
- European Union
- EUDAMED actor, 5 certificates
Catalogue
Search and filter all 843 devicesShowing 1-50 of 843
Company details
- EUDAMED SRN
- DK-MF-000019782
- EU VAT number
- 63450715
- EUDAMED status
- Active
- EUDAMED registered name
- SP Medical A/S
- Registered address
- 1, Møllevej, 4653, Karise, Denmark
- Website
- sp-medical.dk/
- [email protected]
- Phone
- +45 56 76 60 00
- PRRC contact
- Mogens Laigaard
EUDAMED certificates
5 certificates5 valid, 0 expiredMDR 5next expiry 18 Nov 2026
TÜV Rheinland LGA Products GmbH 0197 5 certificates
- HZ 2320977-1 Active
Quality management system EU MDR
- Issued
- 22 Sep 2026
- Expires
- 18 Nov 2031
- Valid from
- 19 Nov 2026
- IZ 2320977-3 Active
Technical documentation EU MDR
- Issued
- 7 Feb 2023
- Expires
- 6 Feb 2028
- IZ 2320977-2 Expiring
Technical documentation EU MDR
- Issued
- 7 Jul 2022
- Expires
- 6 Jul 2027
- IZ 2320977-1 Expiring
Technical documentation EU MDR
- Issued
- 7 Jul 2022
- Expires
- 28 Mar 2027
- Reason
- Other
- HZ 2320977-1 Restricted
Quality management system EU MDR
- Issued
- 29 Jan 2026
- Expires
- 18 Nov 2026
- Valid from
- 26 Feb 2026
- Reason
- Other
From the company website
SP Medical designs and manufactures guide wires with friction reducing coating, hydrophilic, hydrophobic, and hybrid constructions with ISO 13485 certified quality systems and OEM partnership support.
Frequently asked questions
How many devices does SP Medical A/S have in the registry?
The registry currently lists 843 devices for SP Medical A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list SP Medical A/S's devices?
Among its 50 most recently registered devices, SP Medical A/S has devices listed in EUDAMED (50 devices).
What risk classes do SP Medical A/S's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SP Medical A/S's devices are Class IIa and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SP Medical A/S?
EUDAMED lists 5 certificates for SP Medical A/S (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 22 Sep 2026.
What are the newest devices from SP Medical A/S in the registry?
The most recently registered devices listed for SP Medical A/S include Accoat Guide Wire, Accoat Standard Guide Wire, Champion PTCA Guide Wire and Poseidon Hydrophilic Nitinol Guide Wire.