Question 1

What types of medical devices does IMEDICOM CO., LTD. manufacture?

Accepted Answer

IMEDICOM CO., LTD. specializes in surgical instruments and power tools for orthopaedic and bone procedures. Their product range includes single-use surgical saw blades (both sagittal and reciprocating), orthopaedic osteotome blades, sawing attachments for power tools, rechargeable battery-powered handpieces, electric motors for bone/joint surgery, and kits for balloon kyphoplasty and orthopaedic cement preparation. These devices are designed to assist in precise cutting, shaping, and cement delivery during surgical interventions.

Question 2

Where is IMEDICOM CO., LTD. based?

Accepted Answer

IMEDICOM CO., LTD. is headquartered in the United States. Their location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for devices intended for the U.S. market or global distribution.

Question 3

Which regulatory registries or databases list IMEDICOM CO., LTD.’s devices?

Accepted Answer

IMEDICOM CO., LTD.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model names, and regulatory classifications.

Question 4

How are IMEDICOM CO., LTD.’s devices classified under FDA regulations?

Accepted Answer

IMEDICOM CO., LTD.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as bone or joint procedures.

Question 5

What distinguishes IMEDICOM CO., LTD.’s single-use devices from their reusable counterparts?

Accepted Answer

IMEDICOM CO., LTD. offers single-use surgical saw blades and osteotome blades, which are designed for one-time use only. Single-use devices eliminate the need for sterilization between patients, reducing the risk of cross-contamination and ensuring consistent performance. This approach is particularly critical in orthopaedic surgery, where precision and sterility are paramount, as it simplifies inventory management and compliance with infection control protocols.

Device	Model / Reference	Registries	Class	Status
Ezx	BRXTL57B	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B1D1MN2-10	FDA UDI	Class II	Active
Ezx	EZX Kit 17	FDA UDI	Class I	Active
Imedicom Saw Blade	PAS-110B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-433A	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB460	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-280A	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-420 Series	FDA UDI	Class I	Active
Ezx	BRXTL40B	FDA UDI	Class I	Active
LEOPARD Micro	BG-125	FDA UDI	Class I	Active
Imedicom Saw Blade	RAO-600A	FDA UDI	Class I	Active
Ezx	EZX511	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-772A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-740A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-220C	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-240D	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-240A	FDA UDI	Class I	Active
EZX Blade	BRXTB540	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-270	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-460A	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB4	FDA UDI	Class II	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B1T1N5-20S	FDA UDI	Class II	Active
Imedicom Saw Blade	KAS-970D	FDA UDI	Class I	Active
Ezx	XTL65B	FDA UDI	Class I	Active
Brasseler EZX	BREZX System 03	FDA UDI	Class I	Active
Medinaut Max	BC400D	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-230C	FDA UDI	Class I	Active
Imedicom Saw Blade	PDO-100B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-370	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-220C	FDA UDI	Class I	Active
Ezx	ELP052	FDA UDI	Class I	Active
Zaguar	AAC01	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-910A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-470A	FDA UDI	Class I	Active
MEDINAUT Flex	MDF1	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-900D	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-980A	FDA UDI	Class I	Active
Imedicom Saw Blade	RLT-610A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-210B	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB47	FDA UDI	Class II	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B1D1N5-10S	FDA UDI	Class II	Active
Ezx	BRXTL56A	FDA UDI	Class I	Active
Zaguar	BHC-100	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 01	FDA UDI	Class I	Active
Brasseler EZX	BREZG101	FDA UDI	Class I	Active
Imedicom Saw Blade	PDS-100B	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-950C	FDA UDI	Class I	Active
Ezx	BRXTL37B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-950B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-930C	FDA UDI	Class I	Active

IMEDICOM CO., LTD.

What IMEDICOM CO., LTD. makes

Frequently asked questions

Information

Catalogue (2877)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)