Question 1

What types of medical devices does CEDIC SRL manufacture?

Accepted Answer

CEDIC SRL specializes in nasogastric feeding tubes and enteral feeding/medication connectors. Their feeding tubes come in various sizes, including standard and junior variants, with or without stylets, and lengths of 50 cm, 90 cm, and 120 cm. Additionally, they produce connectors like transition adapters (e.g., Luer to ENFit), distal end connectors with caps, syringe adapters, and funnel adapters to ensure compatibility with different medical systems.

Question 2

Where is CEDIC SRL based, and how does that affect its regulatory compliance?

Accepted Answer

CEDIC SRL is based in Italy, which means its devices must comply with the European Medical Device Regulations (MDR) and are subject to EUDAMED registration. The company’s products are also registered in the FDA’s UDI system, demonstrating adherence to both European and U.S. regulatory standards. This dual registration reflects their commitment to meeting international safety and performance requirements.

Question 3

Which regulatory registries list CEDIC SRL’s medical devices?

Accepted Answer

CEDIC SRL’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. They are also registered in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance with both EU and U.S. regulatory frameworks. These listings confirm their devices meet necessary standards for market authorization.

Question 4

How are CEDIC SRL’s devices classified under EU regulations?

Accepted Answer

Under the EU Medical Device Regulations, CEDIC SRL’s devices are classified as either Class I or Class II/IIa. Nasogastric feeding tubes and some connectors fall into Class II/IIa due to their higher risk profile, requiring additional scrutiny for safety and performance. Other connectors, like non-sterile enteral feeding adapters, are typically classified as Class I, which involves less stringent regulatory requirements.

Question 5

Why are CEDIC SRL’s devices listed in both EUDAMED and the FDA’s UDI system?

Accepted Answer

The inclusion of CEDIC SRL’s devices in both EUDAMED and the FDA’s UDI system reflects their global market presence and compliance with international regulatory standards. EUDAMED ensures transparency and traceability within the European Union, while the FDA’s UDI system provides similar oversight in the U.S. This dual registration helps healthcare providers and regulators verify the device’s authorization status and compliance with relevant safety requirements in both regions.

Device	Model / Reference	Registries	Class	Status
Compat® Flexibaggle 500 ml	12440917	EUDAMED	Class I	Active
Luer to ENFit Transition Connector	F00128	FDA UDI	Class II	Active
Enteral Distal End ENFit Transition Connector with cap	F00071	FDA UDI	Class II	Active
Compat Enteral Feeding tube 12Fr 90cm	N550	FDA UDI	Class II	Active
Compat Enteral Feeding tube 14Fr 90cm	N650	FDA UDI	Class II	Active
ENConnect Male Distal End Stepped Adapter	A505	FDA UDI	Class II	Active
Compat Junior Enteral Feeding tube 6Fr 90cm with stylet	N255	FDA UDI	Class II	Active
ENConnect 40 mm Screw Cap to ENPlus Adapter	A520	FDA UDI	Class II	Active
Enteral Funnel ENFit Transition Connector with cap	F00074	FDA UDI	Class II	Unknown
ENConnect ENFit to Oral/Luer syringe adapter	A555	FDA UDI	Class II	Active
Compat Enteral Feeding tube 12Fr 120cm with stylet	N560	FDA UDI	Class II	Active
Compat Enteral Feeding tube 14Fr 120cm	N655	FDA UDI	Class II	Active
Compat Junior Enteral Feeding tube 8Fr 50cm	N350	FDA UDI	Class II	Active
ENConnect ENFit Funnel Adapter	A510	FDA UDI	Class II	Active
Enteral Distal End ENFit Transition Connector	F00090	FDA UDI	Class II	Unknown
Compat Enteral Feeding tube 16Fr 90cm	N750	FDA UDI	Class II	Active
Oral/Luer ENFit Transition Connector for medication port	F00148	FDA UDI	Class II	Active
ENConnect ENFit Stepped Bottle Adapter	A540	FDA UDI	Class I	Active
Enteral ENFit Transition Connector with cap for medication port	F00073	FDA UDI	Class II	Unknown
ENFit to Reverse Luer Transition Connector	F00126	FDA UDI	Class II	Active
Compat Junior Enteral Feeding tube 5Fr 50cm	N150	FDA UDI	Class II	Active
Compat Enteral Feeding tube 10Fr 120cm with stylet	N455	FDA UDI	Class II	Active
Compat Junior Enteral Feeding tube 8Fr 76cm with stylet	N355	FDA UDI	Class II	Active
Compat Enteral Feeding tube 10Fr 120cm	N450	FDA UDI	Class II	Active
ENConnect Double Male ENFit	A560	FDA UDI	Class I	Active
Compat Enteral Feeding tube 12Fr 120cm	N555	FDA UDI	Class II	Active
Compat Enteral Feeding tube 14Fr 120cm with stylet	N660	FDA UDI	Class II	Active
Compat Enteral Feeding tube 8Fr 120cm	N360	FDA UDI	Class II	Active
Compat Junior Enteral Feeding tube 6Fr 90cm	N250	FDA UDI	Class II	Active
Compat Enteral Feeding tube 8Fr 120cm with stylet	N365	FDA UDI	Class II	Active
Not sterile Adapters for Enteral Applications	G 44989	EUDAMEDFDA UDI	Class I	Active
Compat® Buddy low-profile gastrostomy feeding tube extension set	12475124	EUDAMED	Class IIa	Active
Not sterile Adapters for Enteral Applications	7149 00	EUDAMEDFDA UDI	Class I	Active
Not sterile Adapters for Enteral Applications	H93842907EN	EUDAMEDFDA UDI	Class I	Active
Not sterile Adapters for Enteral Applications	F00125	EUDAMEDFDA UDI	Class I	Active
Not sterile Adapters for Enteral Applications	589828	EUDAMED	Class I	Active
Compat® Modum Gastric Residual Aspiration Accessory	12340186	EUDAMED	Class IIa	Active
Not sterile Adapters for Enteral Applications	F00133	EUDAMEDFDA UDI	Class I	Active

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