Question 1

What types of medical devices does Sakura Kenkyusho, K.K. manufacture?

Accepted Answer

Sakura Kenkyusho, K.K. specializes in ear microsystem seeds and pellets, including conical pellets. These devices come in various materials like titanium, stainless steel, gold-plated, and silver, and are often paired with adhesive tapes in clear or tan colors. Some variants are sold with or without latex and may be packaged or sold without packaging.

Question 2

Where is Sakura Kenkyusho, K.K. based?

Accepted Answer

Sakura Kenkyusho, K.K. operates from the United States, as indicated in their regulatory documentation.

Question 3

Which regulatory registries list Sakura Kenkyusho, K.K.’s devices?

Accepted Answer

Sakura Kenkyusho, K.K.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. regulatory requirements for medical devices.

Question 4

How are Sakura Kenkyusho, K.K.’s devices classified under U.S. regulations?

Accepted Answer

Sakura Kenkyusho, K.K.’s devices fall under Class I classification, which is the lowest risk category for medical devices in the U.S. This classification typically means they pose minimal risk to patients and are subject to less stringent regulatory oversight compared to higher-risk devices.

Device	Model / Reference	Registries	Class	Status
Magrain Silver with Tan Color Tape, without pack	8010101	FDA UDI	Class I	Active
Accu-Patch Titanium with Clear tape	8010129	FDA UDI	Class I	Active
Accu-Patch Conical Pellets with Tan Color Tape, with Latex	8010166	FDA UDI	Class I	Active
Magrain Gold with Tan Color Tape, without pack, with Latex	8010011	FDA UDI	Class I	Active
Accu-Patch Stainless steel type with tan color tape	8010120	FDA UDI	Class I	Active
Accu-Patch Gold Plated type with Tan color tape with Latex	8010141	FDA UDI	Class I	Active
Magrain Silver with Clear Tape, without pack	8010105	FDA UDI	Class I	Active
Accu-Patch Stainless steel type with clear tape	8010119	FDA UDI	Class I	Active
Accu-Patch Stainless steel type with Tan color tape with Latex	8010140	FDA UDI	Class I	Active
Magrain Gold with Clear Tape, without pack	8010107	FDA UDI	Class I	Active
Magrain Silver with Tan Color Tape, without pack, with Latex	8010010	FDA UDI	Class I	Active
Magrain Conical Pellets with Tan Color Tape, without pack, with Latex	8010155	FDA UDI	Class I	Active
Magrain Gold with Tan Color Tape, without pack	8010103	FDA UDI	Class I	Active
Accu-Patch Conical Pellets with Tan Color Tape	8010162	FDA UDI	Class I	Active
Magrain-5 Silver Type, without pack	8010109	FDA UDI	Class I	Active
Magrain-5 Silver Type, without pack, with Latex	8010131	FDA UDI	Class I	Active
Accu-Patch Gold Plated type with Tan Color tape	8010122	FDA UDI	Class I	Active
Magrain Conical Pellets with Tan Color Tape, without pack	8010151	FDA UDI	Class I	Active
Accu-Patch Gold Plated type with Clear Tape	8010121	FDA UDI	Class I	Active

SAKAMURA KENKYUSHO, K.K.

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