Data / Medical devices / Singapore / New Beginnings (singapore) Pte. Ltd.
New Beginnings (singapore) Pte. Ltd.: FDA-registered device maker in singapore Central Singapore, Singapore, 1 510(k) clearance
New Beginnings (singapore) Pte. Ltd. is registered with the FDA (registration 3031982537) in singapore Central Singapore, Singapore. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2022. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3031982537
- Address
- 112 Robinson Road #03-01 Robinson 112, singapore Central Singapore, Singapore, 068902
- Owner or operator
- NEW BEGINNINGS (SINGAPORE) PTE. LTD. (10091280)
- Roles
- Exporter to the US
- First device listed
- August 8, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 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 |
| Gown, Surgical | FYA | 2 | 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 21, 2022 | K213893 | Comfort Gown, Safewear Gown | FYA | Substantially Equivalent | Xuchang Zhengde Environstar Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Bandage, Elastic
- All makers of Gown, Surgical
Updated December 21, 2022. 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.