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
9713	9713	EUDAMED	Class IIa	Active
9780	9780	EUDAMED	Class IIa	Active
9369	9369	EUDAMED	Class IIa	Active
Sil100160	SIL100160	EUDAMED	Class I	Active
9367	9367	EUDAMED	Class IIa	Active
9405	9405	EUDAMED	Class IIa	Active
9781	9781	EUDAMED	Class IIa	Active
9363	9363	EUDAMED	Class IIa	Active
9301	9301	EUDAMED	Class I	Active
9270	9270	EUDAMED	Class IIa	Active
S4x7	S4x7	EUDAMED	Class I	Active
9404	9404	EUDAMED	Class IIa	Active
9284	9284	EUDAMED	Class IIa	Active
9055	9055	EUDAMED	Class IIa	Active
952-0032	952-0032	EUDAMED	Class IIa	Active
9361	9361	EUDAMED	Class IIa	Active
S7x10	S7x10	EUDAMED	Class I	Active
9302	9302	EUDAMED	Class I	Active
9249	9249	EUDAMED	Class IIa	Active
9362	9362	EUDAMED	Class IIa	Active
9351	9351	EUDAMED	Class I	Active
Sil040070	SIL040070	EUDAMED	Class I	Active
9366	9366	EUDAMED	Class IIa	Active
9327	9327	EUDAMED	Class I	Active
S4x4	S4x4	EUDAMED	Class I	Active
Silicone Tube	SIL050080	EUDAMED	Class I	Active
Sil050090	SIL050090	EUDAMED	Class I	Active
9292	9292	EUDAMED	Class IIa	Active
9258	9258	EUDAMED	Class IIa	Active
S7x7	S7x7	EUDAMED	Class I	Active
Sterile Cover	9583	EUDAMED	Class I	Active
9250	9250	EUDAMED	Class IIa	Active
Silicone Tube	SIL060090	EUDAMED	Class I	Active
9402	9402	EUDAMED	Class IIa	Active
9370	9370	EUDAMED	Class IIa	Active
9294	9294	EUDAMED	Class IIa	Active
9287	9287	EUDAMED	Class IIa	Active
9709	9709	EUDAMED	Class I	Active
9553a	9553A	EUDAMED	Class I	Active
9289	9289	EUDAMED	Class IIa	Active
9476	9476	EUDAMED	Class IIa	Active
9313	9313	EUDAMED	Class I	Active
9743	9743	EUDAMED	Class IIa	Active
9242	9242	EUDAMED	Class IIa	Active
Brcd-Xl-Ste	BRCD-XL-STE	EUDAMED	Class I	Active
9376	9376	EUDAMED	Class IIa	Active
9462	9462	EUDAMED	Class IIa	Active
Diffusion Set	9752	EUDAMED	Class IIa	Active
9327a	9327A	EUDAMED	Class I	Active
9262	9262	EUDAMED	Class IIa	Active

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