Question 1

What types of medical devices does Richter Rubber Technology Sdn. Bhd. manufacture?

Accepted Answer

Richter Rubber Technology Sdn. Bhd. specializes in basic male condoms made from Hevea-latex. These devices are primarily designed for contraception and protection against sexually transmitted infections. The company’s portfolio includes multiple variants under the Primeros brand and a separate line called Inspire, all falling under the category of barrier contraceptives.

Question 2

Where is Richter Rubber Technology Sdn. Bhd. based?

Accepted Answer

The company is headquartered in Malaysia, where it operates as a manufacturer of latex-based medical devices. Its location in Malaysia influences regulatory compliance requirements, particularly for devices marketed in regions like the EU and the US.

Question 3

Which regulatory registries list Richter Rubber Technology’s devices?

Accepted Answer

Richter Rubber Technology’s devices are recorded in two key regulatory databases: EUDAMED (the European Union’s medical device registry) and the FDA’s UDI system (Unique Device Identifier database in the United States). These registries track device information for transparency and compliance purposes, ensuring traceability across markets.

Question 4

How are Richter Rubber Technology’s devices classified under medical device regulations?

Accepted Answer

The company’s products are classified as Class II or Class IIa/IIb medical devices. This classification is determined by factors like the risk associated with the device’s use (e.g., contraception and STI protection) and its intended purpose. Class II devices typically require additional controls beyond general good manufacturing practices to ensure safety and performance.

Device	Model / Reference	Registries	Class	Status
Primeros	Innocent 3's	FDA UDI	Class II	Active
Primeros	Passion 3's	FDA UDI	Class II	Active
Primeros	Lesbian Pride Hookup 9 x 3s	FDA UDI	Class II	Active
Primeros	Pansexual Pride Hookup 9x3's	FDA UDI	Class II	Active
Primeros	Bisexual Pride Hookup 9 x 3's	FDA UDI	Class II	Active
Inspire	Ultra Thin 12's	FDA UDI	Class II	Active
Primeros	Asexual Pride Hookup 9 x 3's	FDA UDI	Class II	Active
Primeros	Safeguard 3's	FDA UDI	Class II	Active
Primeros	Trans Pride Hookup 9 x 3's	FDA UDI	Class II	Active
Primeros	Softglide 3's	FDA UDI	Class II	Active
Primeros	Non-Binary Pride Hookup 9 x 3's	FDA UDI	Class II	Active
Primeros	Rainbow Pride Hookup 9 x 3's	FDA UDI	Class II	Active
Inspire	Standard 12's	FDA UDI	Class II	Active
Primeros	Gender Queer Pride Hookup 9 x 3's	FDA UDI	Class II	Active
Primeros	Treesome 3's	FDA UDI	Class II	Active
Primeros	The King 3's	FDA UDI	Class II	Active
Primeros	Performance 3's	FDA UDI	Class II	Active
Primeros	Gay Pride Hookup 9 X 3's	FDA UDI	Class II	Active
Primeros	Nighthawk 3's	FDA UDI	Class II	Active
Primeros	Classy 3's	FDA UDI	Class II	Active
My. Size Classic 47	QA-224	EUDAMED	Class IIb	Active
EXS Black Latex	QA-224	EUDAMED	Class IIb	Active
You & Me Romeo	QA-224	EUDAMED	Class IIb	Active
Primeros passion	QA-224	EUDAMED	Class IIb	Active
Love Match Stimolante	QA-224	EUDAMED	Class IIb	Active
EXS Gold Medal	QA-224	EUDAMED	Class IIb	Active
Onsize 47	QA-224	EUDAMED	Class IIb	Active
Love Match Classico	QA-224	EUDAMED	Class IIb	Active
Vitalis Premium Super Thin	QA-224	EUDAMED	Class IIb	Active
EXS Gold Medal	QA-224	EUDAMED	Class IIb	Active
My. Size Pro 64	QA-224	EUDAMED	Class IIb	Active
Condonia White Label	QA-224	EUDAMED	Class IIb	Active
ON) Super Thin	QA-224	EUDAMED	Class IIb	Active
Do It London	QA-279	EUDAMED	Class IIb	Active
EXS Cooling	QA-224	EUDAMED	Class IIb	Active
Mylubie Ultra Thin	QA-224	EUDAMED	Class IIb	Active
EXS Extra Thick	QA-224	EUDAMED	Class IIb	Active
Viva Lube	QA-279	EUDAMED	Class IIb	Active
My. Size Pro 60	QA-224	EUDAMED	Class IIb	Active
EXS Warming	QA-224	EUDAMED	Class IIb	Active
Love Match Aromatizzato	QA-224	EUDAMED	Class IIb	Active
EXS Regular	QA-224	EUDAMED	Class IIb	Active
Sonosafe Probe Cover 28mm	QA-280	EUDAMED	Class IIa	Active
My. Size Pro 69	QA-224	EUDAMED	Class IIb	Active
My. Size Classic 64	QA-224	EUDAMED	Class IIb	Active
My. Size Classic 60	QA-224	EUDAMED	Class IIb	Active
Vitalis Premium XXXL	QA-224	EUDAMED	Class IIb	Active
EXS Regular	QA-224	EUDAMED	Class IIb	Active
EXS Ribbed & Dotted	QA-224	EUDAMED	Class IIb	Active
My. Size Classic 57	QA-224	EUDAMED	Class IIb	Active

RICHTER RUBBER TECHNOLOGY SDN. BHD.

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