SKORE WARM Warming lubricant with smoky fragrance coloured, ribbed, dotted & sh…

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref PM01O

by Ttk Healthcare Limited - Protective Devices Division

Identity

Trade Name: SKORE WARM Warming lubricant with smoky fragrance coloured, ribbed, dotted & shaped EUDAMED
SKORE Bulbous Condoms FDA UDI
Generic Name: Basic male condom, Hevea-latex FDA UDI
Device Name: Condom EUDAMED
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). FDA UDI
Model / Reference: PM01O EUDAMED
SKORE Warm FDA UDI
Description: 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). FDA UDI

Identifiers

Primary DI / UDI-DI: 08906007135559 EUDAMEDFDA UDI
Basic UDI-DI: B-08906007135559 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
Market of Registration: Netherlands EUDAMED
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 WARM Warming lubricant with smoky fragrance coloured, ribbed, dotted & sh… by Ttk Healthcare Limited - Protective Devices Division — Class IIb — MDD…

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-08906007135559	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 bdb13927-cb19-4c5a-9f3c-54b5521e84af 61 fields · synced Oct 9, 2026
FDA UDI 64422298-e3de-4166-9892-6f968eee0c8f 35 fields · synced May 30, 2026