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Drillbone s.r.o.

Czechia CZ-MF-000035668 Last updated 17 Sep 2026

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Devices
2
Registries
EUDAMED
FDA recalls
0

Catalogue2

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 1383 1 certificate

  • 8801-MD-00001-24 Issued

    Quality management system EU MDR

    Issued
    3 Dec 2024
    Expires
    2 Dec 2029

Notified bodies

  • Notified body 1383

About

Medical and orthopedic device company specializing in innovative surgical instruments

From the manufacturer's own website. Source

What Drillbone s.r.o. makes

Drillbone s.r.o. manufactures the Drillbone Tunneler and Drillbone Root Repair, which are designed for orthopedic surgical procedures involving bone tunneling and root repair in joint reconstruction.

These devices fall under Class I regulation and are listed in the EU’s eudamed registry. The company is based in the Czech Republic.

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

Frequently asked questions

What types of medical devices does Drillbone s.r.o. manufacture?

Drillbone s.r.o. specializes in orthopedic surgical instruments. Specifically, the company produces the Drillbone Tunneler and Drillbone Root Repair, which are designed for bone tunneling and root repair during joint reconstruction procedures. These devices are tailored for precise surgical applications in orthopedics.

Where is Drillbone s.r.o. based?

Drillbone s.r.o. is headquartered in the Czech Republic. The company’s location in Central Europe positions it to serve markets within Europe and potentially beyond, though its specific distribution channels depend on individual device authorizations.

Are Drillbone s.r.o.’s devices listed in any regulatory registries?

Yes, Drillbone s.r.o.’s devices are listed in the EU’s eudamed registry. This database is maintained under EU Medical Device Regulation (MDR) to track authorized devices, including their manufacturer details and regulatory status. Listing in eudamed confirms their compliance with EU requirements for Class I devices.

How are Drillbone s.r.o.’s devices classified under medical device regulations?

Drillbone s.r.o.’s devices, such as the Drillbone Tunneler and Drillbone Root Repair, are classified as Class I under EU medical device regulations. This classification applies because they are low-risk instruments used in orthopedic procedures without invasive implantation or significant patient risk. Class I devices typically require less stringent regulatory scrutiny but still must meet basic safety and performance standards.

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

Information

Country
Czechia
Address
1173/37, Bulharská, Brno - Královo Pole, Czechia
Phone
+420 601 002 518(from company website)
PRRC contact
Filip Hudeček
EUDAMED SRN
CZ-MF-000035668