Data / Medical devices / India / TTK Healthcare Limited
TTK Healthcare Limited: FDA-registered device maker in Puducherry, India, 5 510(k) clearances
TTK Healthcare Limited is registered with the FDA (registration 3003902978) in Puducherry, India. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated September 7, 2023. Registered through 2027. FDA data exported November 2, 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
- 3003902978
- Address
- 12, K P Natham Road, Thiruvandar Koil, Puducherry, India, 605102
- Owner or operator
- TTK Healthcare Limited (10046893)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 27, 2014
- Registered through
- 2027
- Brand names listed
- SKORE, SKORE Bulbous Dots & Ribs Natural, SKORE Bulbous Natural, SKORE Dots Natural, SKORE Natural, Sustain Natural Extra Large Ribs and Dots
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 7, 2023 | K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | HIS | Substantially Equivalent | Ttk Healthcare Limited | accessdata.fda.gov |
| December 23, 2021 | K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | HIS | Substantially Equivalent | Ttk Healthcare Limited | accessdata.fda.gov |
| April 15, 2021 | K202403 | SKORE (Colors & Flavors), SKORE (Colors) | HIS | Substantially Equivalent | Ttk Healthcare Limited | accessdata.fda.gov |
| October 20, 2014 | K132490 | SKORE AND MULTIPLE BRANDS | HIS | Substantially Equivalent | Ttk Protective Devices Limited (Formerly Ttk-Lig L | accessdata.fda.gov |
| May 1, 2014 | K131866 | SUSTAIN | HIS | Substantially Equivalent | Hollender Sustainable Brands, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 7, 2023. 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.