Question 1

What types of medical devices does Medica Corp. manufacture?

Accepted Answer

Medica Corp. specializes in reusable surgical instruments for endoscopic and laparoscopic procedures, including monopolar and bipolar electrosurgical electrodes, trocar blades, irrigation/aspiration cannulae, and laparoscopic surgical kits. Additionally, they produce in-vitro diagnostics (IVDs) such as electrolyte calibrators, ion-selective analysers, blood gas controls, and electrolyte solution packs for laboratory testing. These devices are designed for both surgical and diagnostic applications.

Question 2

Where is Medica Corp. based, and what regulatory databases list their devices?

Accepted Answer

Medica Corp. is based in the United States. Their devices are listed in the EUDAMED database under EU medical device regulations and in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking in both European and U.S. markets.

Question 3

How are Medica Corp.’s devices classified under EU regulations?

Accepted Answer

Medica Corp.’s devices fall under three classification tiers in the EU: Class I (generally low-risk devices), Class II (moderate-risk devices requiring additional safety measures), and Class B (a subset of Class II devices with higher risk due to their surgical or invasive nature). Classification is determined by factors like intended use, duration of contact with the body, and potential risks, ensuring appropriate regulatory oversight.

Question 4

What kinds of in-vitro diagnostics (IVDs) does Medica Corp. produce?

Accepted Answer

Medica Corp. manufactures IVDs focused on electrolyte and blood gas analysis, including calibrators for electrolyte analysers, ion-selective electrodes (e.g., for sodium, potassium, and chloride), multiple analyte blood gas controls, and electrolyte solution packs (e.g., EasyLyte Neo). These products are designed to support accurate laboratory testing for clinical decision-making.

Question 5

Why are some of Medica Corp.’s devices listed in the FDA’s UDI system?

Accepted Answer

The FDA’s Unique Device Identifier (UDI) system assigns a unique code to medical devices to improve tracking, transparency, and post-market surveillance. Medica Corp.’s devices are included in this system because they are marketed in the U.S., where UDIs are mandatory for certain classes of devices to ensure patient safety, regulatory compliance, and efficient recall management if needed.

Device	Model / Reference	Registries	Class	Status
EasyLyte Neo 1200ml Solution Pack	30202	EUDAMED	Class B	Active
EasyLyte Neo Ca Electrode	30150	EUDAMED	Class B	Active
EasyLyte Neo Sodium Electrode	30102	EUDAMED	Class B	Active
EasyLyte Neo 600mL Solution Pack	30201	EUDAMED	Class B	Active
EasyLyte Neo Potassium Electrode	30101	EUDAMED	Class B	Active
EasyLyte Neo Cl Electrode	30103	EUDAMED	Class B	Active
ISE Reagent Pack	5420-0000	FDA UDI	Class II	Active
pO2 Electrode	6203	FDA UDI	Class II	Active
Microlap 310mm insert with 2 movable Fenestrated jaws length 20mm	LIL-IP-2F2-31	FDA UDI	Class II	Active
Reusable cannula trocar with lock tap D=3.5mm L=60mm	COEC35060RO	FDA UDI	Class II	Active
MicroLap Aspiration Cannula 200mm	LIL-PC-20	FDA UDI	Class II	Active
HD Laparoscope, 3, 3mm, 0°, autoclavable	LIL-OPT-0	FDA UDI	Class II	Active
Microlap - 200 mm SEMM insert 2 movable jaws	LIL-IP-2SM-20	FDA UDI	Class II	Active
MicroLap Bipolar Forceps - Handle	LIL-H-BP	FDA UDI	Class II	Active
pH Electrode	6201	FDA UDI	Class II	Active
Cannula 3.5mm x 120mm with stopcock	COEC35120RO	FDA UDI	Class II	Active
Na/K/Cl/Li Solution Pack	2026	FDA UDI	Class II	Active
MicroLap Blue Peek Handle	LIL-H-BP1	FDA UDI	Class II	Active
MicroLap Clutch Grasping Forceps, Jaw Insert 200mm	LIL-IP-CL-20	FDA UDI	Class II	Active
C35-Thin 20mm Fenestrated insert L=330mm D=3, 5mm	C35-IP-TF2-33	FDA UDI	Class II	Active
Wash1 Kit	10680	FDA UDI	N/A	Active
MicroLap - Fenestrated jaws Insert length 20mm, 200mm	LIL-IP-F20-20	FDA UDI	Class II	Active
MicroLap Blue Handle with ratchet	LIL-H-BA2	FDA UDI	Class II	Active
MicroLap Bipolar Forceps - Over Tube 200mm	LIL-BTU-20	FDA UDI	Class II	Active
Internal Filling Solution	2492	FDA UDI	Class II	Active
MicroLap Green Handle with ratchet	LIL-H-GA2	FDA UDI	Class II	Active
Potassium Electrode	2101	FDA UDI	Class II	Active
Reusable Cannula Trocar With Lock Tap D=3.5mm L=60mm	COEC35060	FDA UDI	Class II	Active
ISE eChloride Electrode	5207	FDA UDI	Class II	Active
CRP Reagent Kit	10228-4	FDA UDI	Class II	Active
MicroLap Monopolar Coagulation Tip L=50cm D=5mm	C05-CT-50	FDA UDI	Class II	Active
Na/K/Ca/pH Solution Pack	2114	FDA UDI	Class II	Active
MicroLap Irrigation Tube Dolphin L=200MM	LIL-CD-20	FDA UDI	Class II	Active
"C" shape dissector L=50cm D=5mm	C05-IP-2DC-50	FDA UDI	Class II	Active
MicroLap Insulated Outer Tube 200mm	LIL-TU-20	FDA UDI	Class II	Active
MicroLap Rounded Stylus 200mm	LIL-RS-20	FDA UDI	Class II	Active
Disposable valve for trocar D=3, 5mm	C35-SEAL-1	FDA UDI	Class II	Active
MicroLap Monopolar "J" Hook 200mm	LIL-JH-20	FDA UDI	Class II	Active
HD3 laparoscope, 5.5mm, 30°, autoclavable, HM	C05-OPT-30	FDA UDI	Class II	Active
MicroLap Trocar with Helical Obturator	LIL-T-120H	FDA UDI	Class II	Active
MicroLap Cannula 75mm	LIL-C-075	FDA UDI	Class II	Active
Na/K/Cl/Ca/Li Solution pack	2124	FDA UDI	Class II	Active
MicroLap Irrigation Tube Dolphin L=310MM	LIL-CD-31	FDA UDI	Class II	Active
MicroLap Green Peek Handle	LIL-H-GP1	FDA UDI	Class II	Active
pH/pCO2/pO2/Na/K/Ca Analyzer	7005	FDA UDI	Class II	Active
Daily Rinse/Cleaning Solution Kit	7118	FDA UDI	Class II	Active
MicroLap Rounded Stylus 330mm	LIL-RS-33	FDA UDI	Class II	Active
"C" shape dissector L=35cm D=5mm	C05-IP-2DC-35	FDA UDI	Class II	Active
pH Electrode	2151	FDA UDI	Class II	Active
MicroLap Monopolar Coagulation Tip 330mm	LIL-CT-33	FDA UDI	Class II	Active

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