Question 1

What types of medical devices does Oy Fluorplast Ab manufacture?

Accepted Answer

Oy Fluorplast Ab specialises in surgical drapes, gowns, and sterile barrier products, such as those used in operating rooms and clinical procedures. Their portfolio also includes disposable protective apparel like isolation gowns and fluid-resistant coverings, which are designed to support infection control and patient safety in healthcare environments.

Question 2

Where is Oy Fluorplast Ab based?

Accepted Answer

Oy Fluorplast Ab is headquartered in Finland, with manufacturing operations located in Petolahti, Ostrobothnia. The company’s location ensures compliance with EU regulatory standards for medical devices.

Question 3

Which EU regulatory registries list Oy Fluorplast Ab’s medical devices?

Accepted Answer

Oy Fluorplast Ab’s devices are listed in the eudamed registry, which is the official EU database for medical device information. This registry ensures transparency and traceability of devices under EU Medical Device Regulations.

Question 4

How are Oy Fluorplast Ab’s medical devices classified under EU regulations?

Accepted Answer

Oy Fluorplast Ab’s devices fall under Class I and Class IIa classifications according to the EU Medical Device Regulations. These classifications are determined based on factors like risk level, intended use, and potential impact on patient safety, with Class IIa representing a moderate risk requiring additional conformity assessments.

Device	Model / Reference	Registries	Class	Status
Sil010030	SIL010030	EUDAMED	Class I	Active
Suction Tube	9317	EUDAMED	Class I	Active
9387	9387	EUDAMED	Class IIa	Active
9239a	9239A	EUDAMED	Class IIa	Active
connector	Y8x8x8	EUDAMED	Class I	Active
9344	9344	EUDAMED	Class IIa	Active
9403	9403	EUDAMED	Class IIa	Active
964-30	964-30	EUDAMED	Class IIa	Active
Sterile Cover	9558	EUDAMED	Class I	Active
Brcd-Ste	BRCD-STE	EUDAMED	Class I	Active
9347	9347	EUDAMED	Class IIa	Active
9255	9255	EUDAMED	Class IIa	Active
Silicone Tube	SIL020040	EUDAMED	Class I	Active
Y6x6x6	Y6x6x6	EUDAMED	Class I	Active
9343	9343	EUDAMED	Class IIa	Active
9316	9316	EUDAMED	Class I	Active
9247	9247	EUDAMED	Class IIa	Active
Silicone Tube	SIL090130	EUDAMED	Class I	Active
9312	9312	EUDAMED	Class I	Active
9392	9392	EUDAMED	Class I	Active
9709a	9709A	EUDAMED	Class I	Active
9260	9260	EUDAMED	Class I	Active
9410	9410	EUDAMED	Class IIa	Active
9473	9473	EUDAMED	Class IIa	Active
9304	9304	EUDAMED	Class I	Active
9285	9285	EUDAMED	Class IIa	Active
9237a	9237A	EUDAMED	Class IIa	Active
9273	9273	EUDAMED	Class IIa	Active
Suction Tube	9322	EUDAMED	Class I	Active
9288	9288	EUDAMED	Class IIa	Active
9293	9293	EUDAMED	Class IIa	Active
9373	9373	EUDAMED	Class IIa	Active
9321a	9321A	EUDAMED	Class I	Active
9287a	9287A	EUDAMED	Class IIa	Active
10125	10125	EUDAMED	Class I	Active
Flushing Set	9744	EUDAMED	Class IIa	Active
Sil030060	SIL030060	EUDAMED	Class I	Active
Suction Tube	9395	EUDAMED	Class I	Active
Flushing Set	9740	EUDAMED	Class IIa	Active
Sterile Cover	9553	EUDAMED	Class I	Active
9345	9345	EUDAMED	Class IIa	Active
9703a	9703A	EUDAMED	Class I	Active
9360	9360	EUDAMED	Class IIa	Active
9375	9375	EUDAMED	Class IIa	Active
9254	9254	EUDAMED	Class IIa	Active
Diffusion Set	9753	EUDAMED	Class IIa	Active
9377	9377	EUDAMED	Class IIa	Active
Video Camera Cover	9548	EUDAMED	Class I	Active
9054	9054	EUDAMED	Class IIa	Active
Insufflation Set	9706	EUDAMED	Class IIa	Active

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