Question 1

What types of medical devices does Endocarts International Limited manufacture?

Accepted Answer

Endocarts International Limited specializes in medical carts and monitoring systems tailored for surgical and procedural settings. Their product range includes morcellator carts, endotransportation carts with tray storage, electrical isolation transformer carts, and monitor carts featuring 32-inch displays. These devices are designed to support medical procedures by providing organized storage, transport, and monitoring solutions.

Question 2

Where is Endocarts International Limited based?

Accepted Answer

Endocarts International Limited is based in the United Kingdom (GB). The company’s location in the UK aligns with its focus on supplying medical devices within the European market, particularly under EU regulatory frameworks.

Question 3

Which regulatory registries list Endocarts International Limited’s devices?

Accepted Answer

Endocarts International Limited’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry tracks devices authorized under EU medical device regulations, ensuring transparency and traceability for stakeholders.

Question 4

How are Endocarts International Limited’s devices classified under EU regulations?

Accepted Answer

Endocarts International Limited’s devices fall under EU Class I classification. This classification is typically assigned to low-risk medical devices, such as carts and monitoring systems, which pose minimal risk to patients and users. Classification determines the regulatory pathway for conformity assessment and market authorization.

Device	Model / Reference	Registries	Class	Status
Morcellator Cart	100460	EUDAMED	Class I	Active
Endotrans cart with 6 Trays	103630EC	EUDAMED	Class I	Active
Vc-2010ent	104565	EUDAMED	Class I	Active
Vc-480	101243	EUDAMED	Class I	Active
Vc-2010mx	103344	EUDAMED	Class I	Active
Mig-20	104490	EUDAMED	Class I	Active
EC-55 Monitor Cart	100450	EUDAMED	Class I	Active
32" Monitor Cart	100931	EUDAMED	Class I	Active
MIG-20 Cart with Transformer	104497	EUDAMED	Class I	Active
MIG-10 Cart with Transformer	104560	EUDAMED	Class I	Active
AES-1 Cart with transformer	103423	EUDAMED	Class I	Active
VC-2010 ENT with 2KvA Isolation Transformer	104564	EUDAMED	Class I	Active
Mig-20	104491	EUDAMED	Class I	Active
Endotrans cart with 10 trays	103631EC	EUDAMED	Class I	Active
Aes-1	103418	EUDAMED	Class I	Active
E-Trans 6	104710	EUDAMED	Class I	Active
VC-2020 with transformer	102180	EUDAMED	Class I	Active
S/N-2 Lens	101310	EUDAMED	Class I	Active
Ff-4	104531GR	EUDAMED	Class I	Active
Endotrans Wide cart with 10 trays	103632EC	EUDAMED	Class I	Active
Vc-2010fms	102141	EUDAMED	Class I	Active
FF-2 Cart	104293	EUDAMED	Class I	Active
S/N-2 Lens	101315	EUDAMED	Class I	Active
Vc-2020	102181	EUDAMED	Class I	Active
FF-4 Cart	104530GR	EUDAMED	Class I	Active
FF-5 Cart with Transformer	104428	EUDAMED	Class I	Active
Vc-2010mc	103330	EUDAMED	Class I	Active
Mig-20 Lite	104711	EUDAMED	Class I	Active
Vc-480	101261	EUDAMED	Class I	Active
Aes-5	102230	EUDAMED	Class I	Active
Endotrans-6 Lockable	100830	EUDAMED	Class I	Active
Endotrans 10 tray cart (no tray)	103627EC	EUDAMED	Class I	Active
Vc-480	101295	EUDAMED	Class I	Active
Vc-2010	103320	EUDAMED	Class I	Active
Mig-10 Lite	104715	EUDAMED	Class I	Active
MIG-10 Cart	104561	EUDAMED	Class I	Active
Vc-480	101285	EUDAMED	Class I	Active
Ec-3	100932	EUDAMED	Class I	Active
Vc-480	101286	EUDAMED	Class I	Active
St-5	104054	EUDAMED	Class I	Active
AES-2 Caiman Cart	103402	EUDAMED	Class I	Active
Procedure Cart	103790	EUDAMED	Class I	Active
Endotrans-10 Lockable	100831	EUDAMED	Class I	Active
Vc-480	101247	EUDAMED	Class I	Active
Vc-2010fms	102143	EUDAMED	Class I	Active
Endotrans 6 tray cart (no tray)	103626EC	EUDAMED	Class I	Active
Vc-480	101420	EUDAMED	Class I	Active
Vc-2010mx	103345	EUDAMED	Class I	Active
Opf-1	106160	EUDAMED	Class I	Active
Endotrans Wide 10 tray cart (no trays)	103628EC	EUDAMED	Class I	Active

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