Data / Medical devices / Germany / Hans Hepp GMBH & Co. KG
Hans Hepp GMBH & Co. KG: FDA-registered device maker in HAMBURG Lower Saxony, Germany, 2 510(k) clearances
Hans Hepp GMBH & Co. KG is registered with the FDA (registration 3003364331) in HAMBURG Lower Saxony, Germany. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 16, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003364331
- Address
- Georgswerder Damm 16, HAMBURG Lower Saxony, Germany, D-20539
- Owner or operator
- HANS HEPP GMBH & CO. KG (9027829)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 6, 2007
- Registered through
- 2027
- Brand names listed
- 100mm x 100mm wound compresses, 600mm x 800mm bandaging cloth A, 6cm x 4m elastic bandage, 8cm x 4m elastic bandage, 96cm x 96cm x 136cm triangular bandages, Disposable Gloves Size L, Patient Examination Gloves, ca. 17,5cm x 9,5cm medical face mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Manufacturer | accessdata.fda.gov |
| Sheet, Burn | FPY | 1 | Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 16, 2017 | K170575 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | LYZ | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corp | accessdata.fda.gov |
| July 6, 2005 | K051498 | DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR | LYZ | Substantially Equivalent | Ever Global Enterprise Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Vinyl Patient Examination Glove
- All makers of Dressing, Wound, Hydrophilic
- All makers of Bandage, Elastic
- All makers of Sling, Arm
- All makers of Tape And Bandage, Adhesive
Updated May 16, 2017. 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.