FDA.reportPublic FDA data

TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION

Matched from indexed company URL: Ttk Healthcare Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96803943005203207TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION1N2026-01-01NO. 20, 21, PERALI ROAD VIRUDHUNAGAR Tamil Nadu IN 626001
30039029783003902978TTK Healthcare Limited1N2026-01-0112, K P Natham Road, Thiruvandar Koil, Puducherry IN 605102

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08906007135351SKORE Dotted Condoms - The SKORE Dotted Condoms - SKORE Belgian chocolate condom is made of natural rubber latex. It is straight walled, dotted, teat ended, brown colored, Belgian chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Dotted Condoms - SKORE Belgian chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)+914442008234deepika.n@ttkhealthcare.com
08906007135351SKORE Dotted Condoms - The SKORE Dotted Condoms - SKORE Belgian chocolate condom is made of natural rubber latex. It is straight walled, dotted, teat ended, brown colored, Belgian chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Dotted Condoms - SKORE Belgian chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)+914442008231kalaivani.b@ttkhealthcare.com
08906007135399SKORE Dotted Condoms - The SKORE Dotted Condoms - SKORE Dots vanilla condom is made of natural rubber latex. It is straight walled, dotted, teat ended, transparent, vanilla flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Dotted Condoms - SKORE Dots vanilla natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)+9144482008234deepika.n@ttkhealthcare.com
08906007135399SKORE Dotted Condoms - The SKORE Dotted Condoms - SKORE Dots vanilla condom is made of natural rubber latex. It is straight walled, dotted, teat ended, transparent, vanilla flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Dotted Condoms - SKORE Dots vanilla natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)+9144482008231kalaivani.b@ttkhealthcare.com
08906007135436SKORE Thin Condoms with Flavors - The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors- SKORE NOTHING Strawberry natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+9144442008231kalaivani.b@ttkhealthcare.com
08906007135436SKORE Thin Condoms with Flavors - The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors- SKORE NOTHING Strawberry natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442008234deepika.n@ttkhealthcare.com
08906007135474SKORE Thin Condoms with Flavors - The SKORE Thin Condoms with Flavors - SKORE NOTHING Chocolate condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, Chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE NOTHING Chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442008231kalaivani.b@ttkhealthcare.com
08906007135474SKORE Thin Condoms with Flavors - The SKORE Thin Condoms with Flavors - SKORE NOTHING Chocolate condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, Chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE NOTHING Chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442004234deepika.n@ttkhealthcare.com
08906007135511SKORE Thin Condoms with Flavors - The SKORE Thin Condoms with flavors - SKORE SKINTHIN condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, silicone oil with Zeus odor masker male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE SKINTHIN natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+9144442008231kalaivani.b@ttkhealthcare.com
08906007135511SKORE Thin Condoms with Flavors - The SKORE Thin Condoms with flavors - SKORE SKINTHIN condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, silicone oil with Zeus odor masker male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE SKINTHIN natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+9144442008234deepika.n@ttkhealthcare.com
08906007135559SKORE Bulbous Condoms - The SKORE Bulbous Condoms - SKORE Warm condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, orange colored male condoms lubricated with silicone oil and warm lubricant. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Bulbous Condoms - SKORE Warm natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442004234deepika.n@ttkhealthcare.com
08906007135559SKORE Bulbous Condoms - The SKORE Bulbous Condoms - SKORE Warm condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, orange colored male condoms lubricated with silicone oil and warm lubricant. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Bulbous Condoms - SKORE Warm natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442004231kaliavani.b@ttkhealthcare.com
08906007135597SKORE Bulbous Condoms - The SKORE Bulbous Condoms - SKORE Cool condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, blue colored male condoms lubricated with silicone oil and cool tropic mint flavor. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Bulbous Condoms - SKORE Cool natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442004234deepika.n@ttkhealthcare.com
08906007135597SKORE Bulbous Condoms - The SKORE Bulbous Condoms - SKORE Cool condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, blue colored male condoms lubricated with silicone oil and cool tropic mint flavor. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Bulbous Condoms - SKORE Cool natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442008231kalaivani.b@ttkhealthcare.com
08906007135634SKORE Benzocaine Condoms - The SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent male condoms lubricated with silicone oil, Zeus and Benzocaine cream. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442008231kalaivani.b@ttkhealthcare.com
08906007135634SKORE Benzocaine Condoms - The SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent male condoms lubricated with silicone oil, Zeus and Benzocaine cream. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).+914442008234deepika.n@ttkhealthcare.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3110191165669216K230049SKORE 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 OUTHIS2023-09-07
1717901932292895K230049SKORE 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 OUTHIS2023-09-07
1717901619449831K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE VanillaHIS2021-12-23
3110192060306884K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE VanillaHIS2021-12-23
3110191295353621K202403SKORE (Colors & Flavors), SKORE (Colors)HIS2021-04-15
1717901865798596K202403SKORE (Colors & Flavors), SKORE (Colors)HIS2021-04-15
1717901622959308K132490SKORE AND MULTIPLE BRANDSHIS2014-10-20
3110191761519265K132490SKORE AND MULTIPLE BRANDSHIS2014-10-20
3110191487556866K131866SUSTAINHIS2014-05-01
1717902027894170K131866SUSTAINHIS2014-05-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIS102023-09-07

PMN#

GUDID#

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