SKORE Blues colored with extra lubrication (vanilla)

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref MBL01A

by Ttk Healthcare Limited - Protective Devices Division

Identity

Trade Name: SKORE Blues colored with extra lubrication (vanilla) EUDAMED
SKORE Smooth Condoms FDA UDI
Generic Name: Basic male condom, Hevea-latex FDA UDI
Device Name: Condom EUDAMED
The SKORE Smooth Condoms - SKORE Blues- Vanilla condom is made of natural rubber latex. It is straight walled, smooth, teat ended, blue colored, 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 Smooth Condoms - SKORE Blues-Vanilla natural rubber latex male condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). FDA UDI
Model / Reference: MBL01A EUDAMED
SKORE Blues - Vanilla FDA UDI
Description: The SKORE Smooth Condoms - SKORE Blues- Vanilla condom is made of natural rubber latex. It is straight walled, smooth, teat ended, blue colored, 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 Smooth Condoms - SKORE Blues-Vanilla natural rubber latex male 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: 08906007135870 EUDAMEDFDA UDI
Basic UDI-DI: B-08906007135870 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 EUDAMED
Class II FDA UDI
Regulation Number: 884.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

Yes

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

SKORE Blues colored with extra lubrication (vanilla) by Ttk Healthcare Limited - Protective Devices Division — Class IIb — MDD, FDA UDI — listed in EUDAMED…

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-08906007135870	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 cf0c9a55-69ee-406c-93de-b866471c447f 61 fields · synced Jun 19, 2026
FDA UDI 61b25af2-dace-45e4-9063-d6ddccd5282b 35 fields · synced May 29, 2026