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aZure Screw-Retained Abutment, Abutment Tip Driver, 24 mm (L)
EUDAMEDClass IIa (EU MDR)
Ref DIASK00002Model Driver
Identity
- Trade Name
- aZure Screw-Retained Abutment, Abutment Tip Driver, 24 mm (L) EUDAMED
- Device Name
- Implant Driver EUDAMED
- Model / Reference
- Driver EUDAMEDDIASK00002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876733078 EUDAMED
- Basic UDI-DI
- 471987675DR0002F8 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 Screw-Retained Abutment, Abutment Tip Driver, 24 mm (L) 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 | 471987675DR0002F8 | 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 (1)
- EUDAMED da457e1b-bf9d-4e29-992b-7685c4d6ee60 61 fields · synced Jul 25, 2026