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MC BIO SRL

Last updated May 24, 2026

What MC BIO SRL makes

MC Bio SRL manufactures reusable orthopedic and maxillofacial surgical instruments, including manual bone files, rasps, curettes, and tack inserters for craniofacial procedures. Their portfolio also includes specialized surgical trays, dental material mixing surfaces, and non-medicated surgical kits for maxillofacial applications, as well as asymmetric scrapers and mallets for precise bone preparation. The company produces non-bioabsorbable craniofacial bone tacks and accessories like organizers and applicators to streamline surgical workflows.

The company’s devices are classified under FDA regulations as Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. These instruments are designed for reusable clinical use and comply with U.S. medical device standards. The manufacturer operates from the United States, adhering to applicable regulatory requirements for surgical and orthopedic tools.

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

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 338319497

Catalogue (56)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
MT Tack organizer	9574450	FDA UDI	Class I	Active
Back Applicator	9570750	FDA UDI	Class I	Active
MC BIO Tack organizer	9570570	FDA UDI	Class I	Active
Advance Set	9574300	FDA UDI	Class I	Active
Long Tip SP	9570567	FDA UDI	Class I	Active
Gbr Modular Set	9575310	FDA UDI	Class I	Active
MCBio Supertack Tack 3mm - N.5	9514010-5	FDA UDI	Class II	Active
Blade - Asym. S (5mm)	38090	FDA UDI	Class I	Active
Asymmetric Scraper box	9575300	FDA UDI	Class I	Active
Blade - Asym. 3XL (10mm)	38070	FDA UDI	Class I	Active
Handle - Straight MDF	38850	FDA UDI	Class I	Active
Starter Set	9574310	FDA UDI	Class I	Active
GBR Academia box	9570900	FDA UDI	Class I	Active
Standard tip	9570550	FDA UDI	Class I	Active
Tank & Blade - Asym. 3XL (10mm)	38960	FDA UDI	Class I	Active
Blade - Straight XL (8mm)	39770	FDA UDI	Class I	Active
Tip with Indexable Stop	9570566	FDA UDI	Class I	Active
Handle - Asym. - SP (TiN)	38036	FDA UDI	Class I	Active
MCBio Supertack Tack 4mm - N.5	9514014-5	FDA UDI	Class II	Active
Blade - Asym. M (6mm)	38080	FDA UDI	Class I	Active
Offset Tip SP	9570860	FDA UDI	Class I	Active
Offset Tip	9570870	FDA UDI	Class I	Active
Stainless Steel Tack Placement Instrument	9570562	FDA UDI	Class I	Active
Long tip	9570650	FDA UDI	Class I	Active
Back Applicator Tip	9570755	FDA UDI	Class I	Active
Straight Scraper Box	9575230	FDA UDI	Class I	Active
Tack Organizer	9570880	FDA UDI	Class I	Active
Tuff Tack Box	9570596	FDA UDI	Class I	Active
Basic Set	9574290	FDA UDI	Class I	Active
Specialist Organizer	9570888	FDA UDI	Class I	Active
Handle - Straight SP (TiN)	30548	FDA UDI	Class I	Active
G-Special box	9570890	FDA UDI	Class I	Active
Mallet	9100340	FDA UDI	Class I	Active
MCBio Supertack Tack 3mm - N.10	9514010-10	FDA UDI	Class II	Active
Supertack box	9570590	FDA UDI	Class I	Active
MCBio Supertack Tack 5mm - N.5	9514020-5	FDA UDI	Class II	Active
Blade - Straight M (6mm)	39810	FDA UDI	Class I	Active
Blade - Straight S (5mm)	39760	FDA UDI	Class I	Active
5 Scraper box	9572510	FDA UDI	Class I	Active
Blade - Asym. XL (8mm)	38060	FDA UDI	Class I	Active
Handle - Asym. - Titanium	38790	FDA UDI	Class I	Active
Aluminium Tack Placement Instrument	9570775	FDA UDI	Class I	Active
Tank & Blade - Straight XL (8mm)	39785	FDA UDI	Class I	Active
Tank & Blade - Straight S (5mm)	39705	FDA UDI	Class I	Active
Tank & Blade - Asym. S (5mm)	38980	FDA UDI	Class I	Active
Handle - Straight - Ergal	30332	FDA UDI	Class I	Active
Blade - Asym. 2XL (9mm)	38050	FDA UDI	Class I	Active
Tank & Blade - Asym. 2XL (9mm)	38940	FDA UDI	Class I	Active
Modular Box	9574572	FDA UDI	Class I	Active
Blade - Straight 2XL (9mm)	39340	FDA UDI	Class I	Active

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