Solventum US LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000044314 FEI 3031841433
Solventum US LLC is a medical device manufacturer based in the United States, with 468 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I and IIa) as of 12 Nov 2026.
- Devices
- 468
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 275
- EUDAMED 255
- FDA 510(k) 2
- Device classes
- FDA Class II 135
- FDA Class I 131
- EU Class I 103
- EU Class IIa 82
- FDA Unclassified 10
- EU Class IIb 5
- Top EMDN categories
- Identifiers
- EUDAMED SRN US-MF-000044314
- FDA FEI 3031841433
- DUNS 119004140
At a glance
EU certificates
3 of 3 in force.
Market reach
- European Union
- EUDAMED actor, 3 certificates
- United States
- FDA FEI
What Solventum US LLC makes
Solventum US LLC manufactures dental composite resins, including flowable restorative materials for tooth repairs, and single-use dental matrix bands for cavity isolation. The company also produces wound care products, such as non-antimicrobial hydrogel dressings and animal-derived wound matrix dressings designed to support tissue regeneration.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, with submissions recorded in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Catalogue
Search and filter all 468 devicesShowing 1-50 of 468
Company details
- EUDAMED SRN
- US-MF-000044314
- FDA FEI number
- 3031841433
- DUNS number
- 119004140
- EUDAMED status
- Active
- EUDAMED registered name
- Solventum US LLC
- Registered address
- 12930, IH 10 West, 78249, San Antonio, United States
- Website
- www.solventum.com
- Phone
- +1 210 255 6721
- PRRC contact
- Harry Janiski
EUDAMED certificates
3 certificates3 valid, 0 expiredMDR 3next expiry 29 Jan 2030
BSI Group The Netherlands B.V. 2797 2 certificates
- MDR 811471 Active
Quality management system EU MDR
- Issued
- 2 Jul 2026
- Expires
- 29 Jan 2030
- Reason
- Add device or group
- MDR 811476 Active
Technical documentation EU MDR
- Issued
- 30 Sep 2026
- Expires
- 29 Jan 2030
- Reason
- Other
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 127416 0004 Active
Quality management system EU MDR
- Issued
- 10 Jun 2025
- Expires
- 9 Jun 2030
Frequently asked questions
How many devices does Solventum US LLC have in the registry?
The registry currently lists 468 devices for Solventum US LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Solventum US LLC's devices?
Among its 50 most recently registered devices, Solventum US LLC has devices listed in EUDAMED (40 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Solventum US LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Solventum US LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Solventum US LLC?
EUDAMED lists 3 certificates for Solventum US LLC (quality management system; technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 30 Sep 2026.
What are the newest devices from Solventum US LLC in the registry?
The most recently registered devices listed for Solventum US LLC include Solventum™ Paradigm™ 5314S, Solventum™ Paradigm™ 5514S, Solventum™ Micropore™ 1533-1 and Solventum™ Micropore™ 1533-0.