Question 1

What types of medical devices does Charmant Inc. manufacture?

Accepted Answer

Charmant Inc. specializes in reusable surgical instruments, focusing primarily on ophthalmic and general surgical applications. Their product range includes body aspiration needles, ophthalmic surgical probes, soft-tissue manipulation forceps (such as tweezers-like tools), eyelid speculums, intraocular scissors, vascular scissors, surgical instrument assist arm components, and specialized handling forceps. These devices are designed for precision in surgical environments, ensuring reliability and ease of use during procedures.

Question 2

Where is Charmant Inc. based, and what regulatory regions do they operate in?

Accepted Answer

Charmant Inc. is headquartered in Japan. Their devices are listed in key regulatory databases, including eudamed (the EU’s medical device registry) and the FDA’s Unique Device Identifier (UDI) system, indicating compliance with both European and U.S. regulatory requirements for reusable surgical instruments. This reflects their adherence to international standards for medical device manufacturing and distribution.

Question 3

How are Charmant Inc.’s devices classified under regulatory frameworks?

Accepted Answer

Charmant Inc.’s devices fall under Class I classification in regulatory categorizations. This classification is typically assigned to low-risk medical devices, such as many reusable surgical instruments, where the risk of harm to patients is minimal. Class I devices often require less stringent regulatory oversight compared to higher-risk categories but still must meet safety, performance, and manufacturing standards.

Question 4

Are Charmant Inc.’s devices listed in any public registries, and why does this matter?

Accepted Answer

Yes, Charmant Inc.’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s UDI system. This visibility in public registries ensures transparency for healthcare providers, regulators, and patients by providing verified information about the devices’ identities, classifications, and regulatory status. Listing in these databases also facilitates traceability and compliance verification during procurement or post-market surveillance.

Question 5

What distinguishes Charmant Inc.’s reusable surgical instruments from other manufacturers?

Accepted Answer

Charmant Inc. emphasizes precision-engineered reusable instruments tailored for ophthalmic and general surgery, including specialized tools like ophthalmic soft-tissue forceps, intraocular scissors, and assist arm components. Their focus on reusable designs aligns with sustainability goals in healthcare while maintaining high standards for sterility and durability. The company’s inclusion in eudamed and FDA UDI further underscores their commitment to regulatory compliance, ensuring their devices meet global safety and performance benchmarks.

Device	Model / Reference	Registries	Class	Status
Micro Forceps CROSS MAX	37-0011	FDA UDI	Class I	Active
Speculum with Locking Screw	37-0063	FDA UDI	Class I	Active
OKA Speculum	37-0046	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 7L	31-5059	FDA UDI	Class I	Active
NAGAHARA Phaco Chopper	37-0031	FDA UDI	Class I	Active
Needle Holder(Slim)	37-0025	FDA UDI	Class I	Active
OHKI Vascular Clamp Short/Angle	30-0302	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 8LL	31-5065	FDA UDI	Class I	Active
Nucleus Sustainer	37-0070	FDA UDI	Class I	Active
Corneal Forceps(Long)	37-0022	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 3L	31-5039	FDA UDI	Class I	Active
OHKI Scraper	30-0002	FDA UDI	Class I	Active
Kuroda-Clip S	31-1104	FDA UDI	Class I	Active
Hook and Spatula	37-0029	FDA UDI	Class I	Active
Wire Speculum with Blade	37-0010	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 9L	31-5069	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 10LLL	31-5076	FDA UDI	Class I	Active
OHKI Micro Scissors	30-0201	FDA UDI	Class I	Active
Vertical Post Tilted	31-5142VT	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 4S	31-5042	FDA UDI	Class I	Active
Ball tip Manipulator	37-0081	FDA UDI	Class I	Active
Needle Holder(Thin tips)	37-0013	FDA UDI	Class I	Active
Mini C Clamp	31-5142MC	FDA UDI	Class I	Active
Fixed Caliper(SC)	37-0047	FDA UDI	Class I	Active
Ohki Baum	30-0103	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 6S	31-5052	FDA UDI	Class I	Active
IOL Hook	37-0002	FDA UDI	Class I	Active
YAGUCHI Chopper	37-0090	FDA UDI	Class I	Active
U-Bar Proximal	31-5142UP	FDA UDI	Class I	Active
Beaupre Cilia Forceps	37-0059	FDA UDI	Class I	Active
Ohki Baum	30-0101	FDA UDI	Class I	Active
Prechopper	37-0024	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 5S	31-5047	FDA UDI	Class I	Active
FJ Clip 12	24-0002	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 10S	31-5072	FDA UDI	Class I	Active
U-Bar Distal	31-5142UD	FDA UDI	Class I	Active
Micro-Forceps CROSS MAX	30-0702	FDA UDI	Class I	Active
Wire Speculum	37-0009	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 4L	31-5044	FDA UDI	Class I	Active
KS-Forceps	37-0048	FDA UDI	Class I	Active
Micro Forceps CROSS MAX(Short)	37-0021	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 8S	31-5062	FDA UDI	Class I	Active
Table Clamp	31-5501TC	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 7LLL	31-5061	FDA UDI	Class I	Active
Fixation Ring	37-0030	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 5L	31-5049	FDA UDI	Class I	Active
Aspirating Speculum(S)	37-0015S	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 5LLL	31-5051	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 8LLL	31-5066	FDA UDI	Class I	Active
Vertical Post Tilted	31-5501VT	FDA UDI	Class I	Active

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