← Back to catalogue
aZure E-System Twist Drill, 3.3 mm (D) x 8.5-15 mm (L)
EUDAMEDClass IIa (EU MDR)
Ref DI0SK20002Model Drill
Identity
- Trade Name
- aZure E-System Twist Drill, 3.3 mm (D) x 8.5-15 mm (L) EUDAMED
- Device Name
- Drill EUDAMED
- Model / Reference
- Drill EUDAMEDDI0SK20002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874672607 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 E-System Twist Drill, 3.3 mm (D) x 8.5-15 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 | 471987675DR0001F6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- INTAI Technology Corp.
- EUDAMED SRN
- TW-MF-000001158
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b4ab29f2-a39b-4a78-9267-3e8c0bbb1fa7 61 fields · synced Jun 19, 2026