Data / Medical devices / Germany / Asia-Med GMBH
Asia-Med GMBH: FDA-registered device maker in Pullach i.I. Bavaria, Germany, 4 510(k) clearances
Asia-Med GMBH is registered with the FDA (registration 9614607) in Pullach i.I. Bavaria, Germany. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 2, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614607
- FEI number
- 3003191258
- Address
- Kirchplatz 1, Pullach i.I. Bavaria, Germany, 82049
- Owner or operator
- ASIA-MED GMBH (9043114)
- Roles
- Exporter to the US
- First device listed
- December 11, 2007
- Registered through
- 2026
- Brand names listed
- TeWa 10KB-Type, TeWa 5CB-Type, TeWa 5JB-Type, TeWa 5KB-Type, TeWa CB-Type, TeWa CJ-Type, TeWa CJ-Type Safe-T Sleeve, TeWa DPB-Type and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 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 2, 2013 | K132896 | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE | MQX | Substantially Equivalent | Asia-Med GmbH and CO KG | accessdata.fda.gov |
| October 14, 2004 | K042063 | PRESS TACK NEEDLE | MQX | Substantially Equivalent | Asia-Med GmbH & Co. Kg. - Werk Suhl | accessdata.fda.gov |
| July 10, 2003 | K031716 | SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE | MQX | Substantially Equivalent | Asia-Med GmbH and CO KG | accessdata.fda.gov |
| July 10, 2001 | K011808 | ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) | MQX | Substantially Equivalent | Asia-Med GmbH and CO KG | accessdata.fda.gov |
Compare with other makers
Updated December 2, 2013. 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.