Data / Medical devices / Australia / Red Coral Acupuncture Supplies
Red Coral Acupuncture Supplies: FDA-registered device maker in Melbourne Victoria, Australia, 3 510(k) clearances
Red Coral Acupuncture Supplies is registered with the FDA (registration 3011105336) in Melbourne Victoria, Australia. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 15, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011105336
- Address
- Suite 3, Level 3, 424 St Kilda Road, Melbourne Victoria, Australia, 3004
- Owner or operator
- Red Coral Acupuncture Supplies (10049001)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- March 30, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 2 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| July 15, 2015 | K150903 | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | MQX | Substantially Equivalent | Maanshan Bond Medical Instruments Co., Ltd. | accessdata.fda.gov |
| February 1, 2006 | K052731 | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Daxin LI | accessdata.fda.gov |
| December 22, 2005 | K052846 | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE | MQX | Substantially Equivalent | Maanshan Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 15, 2015. 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.