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aZure C-system Final Implant Drill,
EUDAMEDClass IIa (EU MDR)
Ref DI0SK10027Model DrillRef DI0SK10024Ref DI0SK10026
Identity
- Trade Name
- aZure C-system Final Implant Drill, EUDAMEDaZure C-system Final Implant Drill EUDAMED
- Device Name
- Drill EUDAMED
- Model / Reference
- Drill EUDAMEDDI0SK10027 EUDAMEDDI0SK10024 EUDAMEDDI0SK10026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874673376 EUDAMED04719874673345 EUDAMED04719874673369 EUDAMED
- Basic UDI-DI
- 471987675DR0001F6 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
aZure C-system Final Implant Drill, by INTAI Technology Corp. — Class IIa — 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 | 471987675DR0001F6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- INTAI Technology Corp.
- EUDAMED SRN
- TW-MF-000001158
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 52f9714c-f951-43bb-bdcd-11bc99e786bc 61 fields · synced Jul 30, 2026
- EUDAMED 0eb24ecd-1fc5-4ec0-8668-13daf12ca6bc 61 fields · synced May 18, 2026
- EUDAMED 30edec00-330b-45a0-8c26-1a553abdfee2 61 fields · synced May 18, 2026