Q: What types of medical devices does MacroLux Medical Technology Co., Ltd. manufacture?

MacroLux Medical Technology Co., Ltd. manufactures ureteral introduction sheaths, flexible video bronchoscopes (single-use), endoscopic video image processing units, flexible video ureteroscopes (single-use), flexible video cystoscopes (single-use), rigid video hysteroscopes, and electromechanical device/system transport trolleys. Examples of specific products include CoralWell, CoralView, BubbleView®, LoopView®, and SeleneView®.

Question 1

What types of medical devices does MacroLux Medical Technology Co., Ltd. manufacture?

Accepted Answer

MacroLux Medical Technology Co., Ltd. makes ureteral introduction sheaths, flexible video bronchoscopes, flexible video ureteroscopes, flexible video cystoscopes, rigid video hysteroscopes, endoscopic video image processing units, and electromechanical device/system transport trolleys. Specific product examples include CoralWell, CoralView, BubbleView®, LoopView®, and SeleneView®.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. MacroLux Medical Technology Co., Ltd. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is MacroLux Medical Technology Co., Ltd. based?

Accepted Answer

MacroLux Medical Technology Co., Ltd. is based in the United States, as stated in the company's country information within the device data.

Question 3

In which regulatory registries are MacroLux Medical Technology Co., Ltd.'s devices listed?

Accepted Answer

The devices manufactured by MacroLux Medical Technology Co., Ltd. are listed in the FDA 510(k) and FDA UDI registries, as indicated in the LISTED IN field of the device data.

Question 4

How are MacroLux Medical Technology Co., Ltd.'s devices classified?

Accepted Answer

MacroLux Medical Technology Co., Ltd.'s devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES information provided in the device data.

Device	Model / Reference	Registries	Class	Status
BubbleView®	C50-CBR	FDA UDI	Class II	Active
CoralWell	NS-1455B	FDA UDI	Class II	Active
Trolley	RS008-101-05	FDA UDI	Class I	Active
CoralWell	NS-1145B	FDA UDI	Class II	Active
CoralWell	NS-1345B	FDA UDI	Class II	Active
ViewHub®	S13	FDA UDI	Class II	Active
LoopView®	B58-C	FDA UDI	Class II	Active
CoralWell	NS-1235B	FDA UDI	Class II	Active
CoralWell	NS-1235B	FDA UDI	Class II	Active
SeleneView®	HO42	FDA UDI	Class II	Active
CoralWell	NS-0945B	FDA UDI	Class II	Active
CoralWell	NS-0840B	FDA UDI	Class II	Active
LoopView®	B50	FDA UDI	Class II	Active
LoopView®	B58-C	FDA UDI	Class II	Active
CoralWell	NS-1345B	FDA UDI	Class II	Active
CoralView®	U20	FDA UDI	Class II	Active
CoralView	U10	EUDAMEDFDA UDI	Class II	Active
LoopView®	B58	FDA UDI	Class II	Active
SeleneView®	HO35-G	FDA UDI	Class II	Active
LoopView®	B38-G	FDA UDI	Class II	Active
Power adapter	Type H	FDA UDI	Class II	Active
LoopView®	B58-CG	FDA UDI	Class II	Active
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)	K260420	FDA 510(k)	Class II	Active
CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)	K250452	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)	K240978	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)	K233779	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)	K231774	FDA 510(k)	Class II	Active
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)	K240283	EUDAMEDFDA 510(k)FDA UDI	Class II	Active

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