FDA Registration
Active
🇩🇪 Germany
Solventum Germany GmbH
Reg #: 3032911850
·
FEI: 3032911850
·
Expires 2026
Products
23
Proprietary Names
10
Establishment Types
5
Classifications
23
Registration Details
- Registration Name
- Solventum Germany GmbH
- Registration Number
- 3032911850
- FEI Number
- 3032911850
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Edisonstrasse 6
- City
- Kamen North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K251999
Owner / Operator
- Firm Name
- Solventum US LLC
- Operator Number
- 10091183
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- JEFFERY J SCHORR
US Agent
- Business Name
- SOLVENTUM US LLC
- Contact Name
- JEFFERY SCHORR
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
- [email protected]
- Phone
- 210 2556721
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 1999-03-19 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 1992-12-03 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-05-18 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2026-05-18 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 1992-12-03 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-10-29 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2006-03-01 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1992-12-03 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2019-11-15 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-02-21 |
| Material, Impression | ELW | Class 2 | Dental | No | 2008-12-11 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2011-05-25 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2008-07-09 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1978-03-31 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2013-01-17 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 1992-12-03 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-07-10 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2001-08-06 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2004-01-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2002-07-11 |
Proprietary Names
Incognito Indirect Bonding Tray
Incognito
Hi-T
Unitek
OPTICLUDE ORTHOPTIC EYE PATCH
OPTICLUDE
3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch
3M(TM) Nexcare(TM) Gentle Removal Eye Patch
Victory Series (TM) Bands
Unitek (TM) Bands
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)