Question 1

What types of medical devices does Surgika srl manufacture?

Accepted Answer

Surgika srl manufactures ophthalmic and procedural kits, including cataract surgery kits, vitrectomy custom packs, suturing kits, medication kits, and urology kits. These are procedure-specific sets designed for clinical use in eye surgery and related medical interventions, as stated in the summary provided.

Question 2

Where is Surgika srl based?

Accepted Answer

Surgika srl is based in Italy, as indicated by the country code IT in the device data and confirmed in the summary section which states the company is based in Italy.

Question 3

In which regulatory registry are Surgika srl's devices listed?

Accepted Answer

Surgika srl's devices are listed in the Eudamed database, as explicitly stated in the DEVICE DATA under LISTED IN: eudamed and reiterated in the summary which confirms the devices are listed in the Eudamed database.

Question 4

How are Surgika srl's devices classified under the EU regulatory framework?

Accepted Answer

Surgika srl's devices are classified as Class I and Class IIa under the EU regulatory framework, as specified in the DEVICE DATA under DEVICE CLASSES: Class I, Class IIa and confirmed in the summary which states the devices are classified as Class I and Class IIa.

Device	Model / Reference	Registries	Class	Status
Pinza Ad Anelli Foerster Cm.25	S09STR0024	EUDAMED	Class IIa	Active
Ma Set Chirurgia Universale Pacco Tavolo Chirurgia	C02GEN0088	EUDAMED	Class I	Active
Drain Drop Basic Tappeto Cm.90x240	C07ALL0907	EUDAMED	Class I	Active
Combinazione Di Curette Willinger Cm.16, 5	S09STR0498	EUDAMED	Class IIa	Active
Guaina Copritelecamera In Pe Trasparente Cm.18x300	S06ALL0108	EUDAMED	Class I	Active
Telo Biplex Cm.75x90 Con Foro Adesivo Cm .6x9	C05ALL0003	EUDAMED	Class I	Active
Campo Per Chirurgia Oftalmica Cm.150x150	S01OPH0251	EUDAMED	Class I	Active
Set Chirurgico Universale Rinforzato	S02GEN0002R	EUDAMED	Class I	Active
Campo Per Parto Cesareo	S01GYN0104	EUDAMED	Class I	Active
Pinza Per Schegge Feilchenfeld Retta Cm.9	S09STR0422	EUDAMED	Class IIa	Active
Drain Drop Basic Tappeto Cm.90x150	S07ALL0805.	EUDAMED	Class I	Active
Numerare 3 Contenitore Di Sicurezza - M10 / 3xm10	AGO1003S	EUDAMED	Class I	Active
Sistema Porta Aghi-Lame Da 20 Posizioni	S07ALL0168	EUDAMED	Class I	Active
Drain Drop Basic Bobina Cm.45x50 Mt	S07ALL0711	EUDAMED	Class I	Active
Set Per Emodinamica	C03ANG0094	EUDAMED	Class IIa	Active
Forbice Chirurgica Retta Cm.14, 5 - Punte Smusse	S09STR0410	EUDAMED	Class IIa	Active

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