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Sign in to claim this brandTtk Healthcare Limited
US
Last updated May 30, 2026
What Ttk Healthcare Limited makes
The company manufactures latex male condoms designed for personal protection during sexual activity. Products include flavored, colored, and textured variants such as smooth, bulbous, and ribbed condoms, as well as extra-large sizes with added tactile features like dots and ribs.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Ttk Healthcare Limited manufacture?
Ttk Healthcare Limited specializes in basic male condoms made from Hevea latex. Their product line includes a variety of designs such as flavored, colored, and textured variants, including smooth, bulbous, ribbed, and extra-large sizes with added tactile features like dots and ribs. These devices are intended for personal protection during sexual activity.
Where is Ttk Healthcare Limited based?
Ttk Healthcare Limited operates from the United States. The company’s headquarters and manufacturing operations are located within the country.
Which regulatory registries list Ttk Healthcare Limited’s devices?
Ttk Healthcare Limited’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track and identify medical devices that have undergone the necessary regulatory processes.
How are Ttk Healthcare Limited’s devices classified under regulatory frameworks?
Ttk Healthcare Limited’s latex male condoms are classified as Class II devices. This classification is determined by regulatory authorities based on the level of risk associated with the device, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ttkhealthcare.com
- —
- —
- [email protected]
- Phone
- +914442008231
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 675476406
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SKORE (Colors) | SKORE Orange | FDA UDI | Class II | Active |
| SKORE Smooth Condoms - SKORE (Colors & Flavors) | SKORE Banana | FDA UDI | Class II | Active |
| SKORE (Colors) | SKORE Yellow | FDA UDI | Class II | Active |
| SKORE Bulbous Natural | SKORE Bulbous | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Banana | FDA UDI | Class II | Active |
| SKORE Smooth Condoms - SKORE (Colors & Flavors) | SKORE Strawberry | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Strawberry | FDA UDI | Class II | Active |
| SKORE Thin Condoms with Flavors | SKORE NOTHING Strawberry | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Pinacolada | FDA UDI | Class II | Active |
| SKORE (Colors) | SKORE Brown | FDA UDI | Class II | Active |
| Sustain Natural Extra Large Ribs and Dots. | Sustain Natural Extra Large Ribs and Dots | FDA UDI | Class II | Active |
| Skore Bulbous Dots And Ribs | BULBOUS DOTS AND RIBS | FDA UDI | Class II | Active |
| SKORE Dots Natural | SKORE Dots | FDA UDI | Class II | Active |
| SKORE Natural | SKORE Natural | FDA UDI | Class II | Active |
| SKORE Benzocaine Condoms | SKORE NOTHING Climax Delay | FDA UDI | Class II | Active |
| SKORE Smooth Condoms - SKORE (Colors & Flavors) | SKORE Vanilla | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Cool Mint | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Chocolate | FDA UDI | Class II | Active |
| SKORE Smooth Condoms - SKORE (Colors & Flavors) | SKORE Tangerine | FDA UDI | Class II | Active |
| SKORE Smooth Condoms - SKORE (Colors & Flavors) | SKORE Chocolate | FDA UDI | Class II | Active |
| SKORE Benzocaine Condoms | SKORE NOT OUT Climax Delay | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Cherry | FDA UDI | Class II | Active |
| SKORE Dotted Condoms | SKORE Belgian Chocolate | FDA UDI | Class II | Active |
| SKORE Thin Condoms with Flavors | SKORE NOTHING Chocolate | FDA UDI | Class II | Active |
| SKORE Benzocaine Condoms | SKORE DUO MAX | FDA UDI | Class II | Active |
| SKORE Bulbous Condoms | SKORE COOL | FDA UDI | Class II | Active |
| SKORE (Colors & Flavors) | SKORE Tangerine | FDA UDI | Class II | Active |
| SKORE (Colors) | SKORE Red | FDA UDI | Class II | Active |
| 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 | K230049 | FDA 510(k) | Class II | Active |
| SKORE (Colors & Flavors), SKORE (Colors) | K202403 | FDA 510(k) | Class II | Active |
| Clincare Latex Surgeon's Glove | K012067 | FDA 510(k) | Class I | Active |
| SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | K213547 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- TTK Healthcare Limited Puducherry · IN FEI 3003902978