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Tiburon Medical Enterprises

United States·US-MF-000012145

Last updated September 17, 2026

What Tiburon Medical Enterprises makes

Tiburon Medical Enterprises makes orthotic insoles that are prefabricated and non-antimicrobial, as well as cervical spinal orthoses and lower extremity orthoses for the hip.

These devices are classified as Class I and are listed in the Eudamed registry; the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Tiburon Medical Enterprises make?

Tiburon Medical Enterprises makes orthotic insoles that are prefabricated and non-antimicrobial, as well as cervical spinal orthoses and lower extremity orthoses for the hip, based solely on the device categories and examples provided in the data.

Where is Tiburon Medical Enterprises based?

Tiburon Medical Enterprises is based in the United States, as explicitly stated in the COUNTRY field of the provided device data.

Which registries list Tiburon Medical Enterprises' devices?

Tiburon Medical Enterprises' devices are listed in the Eudamed registry, as indicated in the LISTED IN field of the provided device data.

How are Tiburon Medical Enterprises' devices classified?

Tiburon Medical Enterprises' devices are classified as Class I, as specified in the DEVICE CLASSES field of the provided device data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 915, Industrial Way, San Jacinto, United States
Website: tiburonmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Juan Ordaz
EUDAMED SRN: US-MF-000012145
FDA FEI Number: 3002935344
DUNS Number: —

Catalogue (121)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Cervical Spinal Orthosis	30072	EUDAMED	Class I	Active
Cervical Spinal Orthosis	30091	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	35365	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	35341	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	32102	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	32173	EUDAMED	Class I	Active
Lower Extremity Orthosis - Hip	27214	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	35305	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	32163	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	32172	EUDAMED	Class I	Active
Cervical Spinal Orthosis	30081	EUDAMED	Class I	Active
Lower Extremity Orthosis - Knee	25182	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0006A-4	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0013B-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0009A-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0008A-2	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0006-M2	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0009A-2	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0002B-2	EUDAMED	Class I	Active
Lower Extremity Orthosis - Foot	22013	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0002-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0011A-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	00FW01-5	EUDAMED	Class I	Active
Lower Extremity Orthosis - Foot	22301	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0006A-0	EUDAMED	Class I	Active
Lower Extremity Orthosis - Foot	22011	EUDAMED	Class I	Active
Lower Extremity Orthosis - Knee	25054	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	00FW07-1	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0002A-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0008-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0002B-1	EUDAMED	Class I	Active
Lower Extremity Orthosis - Foot	27323	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	00FW07-4	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0005A-1	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0002B-4	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0005-0	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0002A-4	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0018-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0008A-1	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0013A-2	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	00FW01-4	EUDAMED	Class I	Active
Lower Extremity Orthosis - Foot	22001	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	00FW07-2	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0013-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0006-0	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0019-1	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0004-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0008A-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0005-3	EUDAMED	Class I	Active
Wrist, Hand, Finger Splint	0009A-1	EUDAMED	Class I	Active

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