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
Twin Cannula	37-0036	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 7LL	31-5060	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 9M	31-5068	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 4M	31-5043	FDA UDI	Class I	Active
YAMANE Double Needle Guide	37-0078	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 10L	31-5074	FDA UDI	Class I	Active
OHKI Vascular Clamp Small Curve	30-0303	FDA UDI	Class I	Active
Corneal Forceps(Short)	37-0023	FDA UDI	Class I	Active
Ohki Baum	30-0102	FDA UDI	Class I	Active
Cilia Forceps CROSS MAX(Blunt tips)	37-0012R	FDA UDI	Class I	Active
Micro Forceps CROSS MAX(Long)	37-0020	FDA UDI	Class I	Active
Eagle Prechopper	37-0076	FDA UDI	Class I	Active
Micro-Forceps (KN)	31-1110	FDA UDI	Class I	Active
Speculum Parallel	37-0026	FDA UDI	Class I	Active
Multi Purpose Scissors(Blunt tips)	37-0061R	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 7S	31-5057	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 8L	31-5064	FDA UDI	Class I	Active
FJ Clip 5	24-0001	FDA UDI	Class I	Active
Micro-Forceps CROSS MAX	30-0701	FDA UDI	Class I	Active
Vertical Post Upright	31-5142VU	FDA UDI	Class I	Active
Kuroda-Clip L	31-1105	FDA UDI	Class I	Active
OHKI Tunneler	30-0501	FDA UDI	Class I	Active
Suture Trabeculotomy Knife	37-0082	FDA UDI	Class I	Active
INAMURA Capsulorrhexis Forceps(Fine)	37-0071	FDA UDI	Class I	Active
Speculum Adjustable	37-0014	FDA UDI	Class I	Active
OHKI Vascular Clamp Long/Angle	30-0304	FDA UDI	Class I	Active
Iris Forceps	37-0007	FDA UDI	Class I	Active
CHUKYO Chopper	37-0034	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 10M	31-5073	FDA UDI	Class I	Active
NAGAHARA Phaco Chopper	37-0031S	FDA UDI	Class I	Active
KS-Manipulator	37-0049	FDA UDI	Class I	Active
Tightening Driver	31-5142TD	FDA UDI	Class I	Active
Capsulorrhexis Forceps	37-0062	FDA UDI	Class I	Active
Multi Purpose Forceps	37-0035	FDA UDI	Class I	Active
Paddle tip Manipulator	37-0080	FDA UDI	Class I	Active
Tying Forceps CROSS MAX(Long)	37-0042	FDA UDI	Class I	Active
OHKI Vascular Clamp Small Curve/Long	30-0305	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 6L	31-5054	FDA UDI	Class I	Active
Pressure Adjustable Micro-Sucker 3S	31-5037	FDA UDI	Class I	Active
KS-Loading Forceps	37-0050	FDA UDI	Class I	Active
Single Cannula	37-0037	FDA UDI	Class I	Active
Caliper with Handle(G)	37-0064	FDA UDI	Class I	Active
Micro Scissors(Blunt tips)	37-0006	FDA UDI	Class I	Active
TOKUDA Chopper	37-0032	FDA UDI	Class I	Active
Sinskey Hook	37-0089	FDA UDI	Class I	Active
NAGAHARA Phaco Chopper	37-0072	FDA UDI	Class I	Active
OHKI Venous Forceps	30-0402	FDA UDI	Class I	Active
Lenticule Forceps Tips(20G)	37-0035A	FDA UDI	Class I	Active
KOZAWA Cilia Forceps	37-0055	FDA UDI	Class I	Active
MS Round-ST-CV 31-16BNHT	31-16BNHT	EUDAMEDFDA UDI	Class I	Active

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