Identity
- Trade Name
- SKORE SKINTHIN EUDAMEDSKORE Thin Condoms with Flavors FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- Condom EUDAMEDThe 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). FDA UDI
- Model / Reference
- MT06S EUDAMEDSKORE SKINTHIN FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08906007135511 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08906007135511 EUDAMED
- 510(k) Number
- K230049 FDA UDI
- FDA Product Code
- HIS FDA UDI
- EMDN Code
- U110101 CONDOMS EUDAMED
- GMDN Term
- Basic male condom, Hevea-latex FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Skore Skinthin by Ttk Healthcare Limited - Protective Devices Division — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08906007135511 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ttk Healthcare Limited - Protective Devices Division
- EUDAMED SRN
- IN-MF-000008508
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 860e5d54-76fc-4d4d-8c53-cf1b48a773d0 61 fields · synced Oct 6, 2026
- FDA UDI a3f8537a-5c90-4bc3-895c-e181bb935b9e 35 fields · synced May 29, 2026