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Dental Burs
EUDAMEDClass I (EU MDR)
Ref TIA-EX-13Model TIA-TR-26EF TIA-TR-25EF TIA-TR-21EF TIA-TR-14EF TIA-TR-13EF TIA-TR-12EF TIA-TR-11EF TIA-TF-21EF TIA-TF-12EF TIA-TC-32EF TIA-TC-31EF TIA-TC-30EF TIA-TC-26EF TIA-TC-21EF TIA-TC-20EF TIA-TC-19EF TIA-TC-17EF TIA-TC-14EF TIA-TC-12EF TIA-TC-11EF
by TiaDent Inc
Identity
- Device Name
- Dental Burs EUDAMED
- Model / Reference
- TIA-TR-26EF TIA-TR-25EF TIA-TR-21EF TIA-TR-14EF TIA-TR-13EF TIA-TR-12EF TIA-TR-11EF TIA-TF-21EF TIA-TF-12EF TIA-TC-32EF TIA-TC-31EF TIA-TC-30EF TIA-TC-26EF TIA-TC-21EF TIA-TC-20EF TIA-TC-19EF TIA-TC-17EF TIA-TC-14EF TIA-TC-12EF TIA-TC-11EF EUDAMEDTIA-EX-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810190266984 EUDAMED
- Basic UDI-DI
- 081019026DBKL EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Burs by TiaDent Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081019026DBKL | Class I | Active |
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Manufacturer
- Manufacturer
- TiaDent Inc
- EUDAMED SRN
- US-MF-000049704
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 18e7f498-9be4-4d8c-8edc-631cc2b65e0d 61 fields · synced Jun 18, 2026