Drillbone s.r.o.
Czechia CZ-MF-000035668 Last updated 17 Sep 2026
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- Devices
- 2
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Drillbone Tunneler Ref 1001
Drillbone Root Repair Ref 1002
EUDAMED certificates
Notified body 1383 1 certificate
- 8801-MD-00001-24 Issued
Quality management system EU MDR
- Issued
- 3 Dec 2024
- Expires
- 2 Dec 2029
Related companies
Notified bodies
- Notified body 1383
About
Medical and orthopedic device company specializing in innovative surgical instruments
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.
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.
Information
- Country
- Czechia
- Address
- 1173/37, Bulharská, Brno - Královo Pole, Czechia
- Website
- www.drillbone.com
- linkedin.com/company/drillbone
- [email protected]
- Phone
- +420 601 002 518
- PRRC contact
- Filip Hudeček
- EUDAMED SRN
- CZ-MF-000035668