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
Pressure Adjustable Micro-Sucker 9LLL	31-5071	FDA UDI	Class I	Active
IOL Hook(straight)	37-0039	FDA UDI	Class I	Active
Needle Holder with Lock(Slim)	37-0057	FDA UDI	Class I	Active
Cilia Forceps(Flat)	37-0038	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 10LL	31-5075	FDA UDI	Class I	Active
Rosen Chopper	37-0067	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 5LL	31-5050	FDA UDI	Class I	Active
Tying Forceps	37-0074	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 9LL	31-5070	FDA UDI	Class I	Active
Fixation Forceps with teeth	37-0060	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 7M	31-5058	FDA UDI	Class I	Active
Needle Holder	37-0008	FDA UDI	Class I	Active
OHKI Venous Forceps	30-0401	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 9S	31-5067	FDA UDI	Class I	Active
SUGITA FLACS Hook	37-0087	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 6M	31-5053	FDA UDI	Class I	Active
Micro Scissors(Acute tips)	37-0005	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 3LLL	31-5041	FDA UDI	Class I	Active
Tying Forceps CROSS MAX(Short)	37-0043	FDA UDI	Class I	Active
OHKI Tunneler	30-0502	FDA UDI	Class I	Active
Kuroda-Clip Applier	31-1106	FDA UDI	Class I	Active
Aspirating Speculum(L)	37-0056	FDA UDI	Class I	Active
Fukushima Universal Holding System	31-5142	FDA UDI	Class I	Active
Capsulorrhexis Forceps	37-0004	FDA UDI	Class I	Active
Vertical Post Upright	31-5501VU	FDA UDI	Class I	Active
SATO Wire Speculum(G)	37-0085	FDA UDI	Class I	Active
Fukushima Universal Holding System	31-5501	FDA UDI	Class I	Active
KS-Loading Forceps	37-0088	FDA UDI	Class I	Active
Table Clamp	31-5142TC	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 3LL	31-5040	FDA UDI	Class I	Active
YOSHITOMI Meibomian Gland Forceps	37-0044	FDA UDI	Class I	Active
Cilia Forceps CROSS MAX	37-0012	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 8M	31-5063	FDA UDI	Class I	Active
Infant Lid Retractor	37-0041	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 3M	31-5038	FDA UDI	Class I	Active
Cilia Forceps(Flat-Blunt tips)	37-0038R	FDA UDI	Class I	Active
TOKUDA Hook	37-0086	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 4LL	31-5045	FDA UDI	Class I	Active
Fixation Forceps with teeth	37-0075	FDA UDI	Class I	Active
Multi Purpose Scissors	37-0061	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 4LLL	31-5046	FDA UDI	Class I	Active
FJ Clip Neo 5	24-0003	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 6LL	31-5055	FDA UDI	Class I	Active
ICHIKAWA Chopper	37-0033	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 6LLL	31-5056	FDA UDI	Class I	Active
Aspirating Speculum	37-0015	FDA UDI	Class I	Active
Wire Speculum Double Loop Open Blade	37-0040	FDA UDI	Class I	Active
Scleral Depressor	37-0083	FDA UDI	Class I	Active
FJ Clip Neo 12	24-0004	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 5M	31-5048	FDA UDI	Class I	Active

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