Data / Medical devices / Germany / Lohmann & Rauscher GMBH & Co. KG
Lohmann & Rauscher GMBH & Co. KG: FDA-registered device maker in NEUWIED Rhineland-Palatinate, Germany, 1 510(k) clearance
Lohmann & Rauscher GMBH & Co. KG is registered with the FDA (registration 3002468342) in NEUWIED Rhineland-Palatinate, Germany. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 1980. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3002468342
- Address
- Heilsberger Strasse 16 --, NEUWIED Rhineland-Palatinate, Germany, 56566
- Owner or operator
- LOHMANN & RAUSCHER GMBH & CO. KG (8010825)
- Roles
- Exporter to the US
- First device listed
- February 14, 1994
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Cast | ITG | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Exporter to the US | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Exporter to the US | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Exporter to the US | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 1980 | K802794 | PRO-OPHTA STICKS | HOZ | Substantially Equivalent | Secol Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Sponge, Ophthalmic
- All makers of Bandage, Elastic
- All makers of Dressing, Compression
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Protector, Skin Pressure
Updated December 22, 1980. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.