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aZure C & E System Twist Drill, 2 mm (D) x 13 mm (L), 14 mm Drill Length
EUDAMEDClass IIa (EU MDR)
Ref DI0SK00063Model DrillRef DI0SK00061
Identity
- Trade Name
- aZure C & E System Twist Drill, 2 mm (D) x 13 mm (L), 14 mm Drill Length EUDAMEDaZure C & E System Twist Drill, 2 mm (D) x 10 mm (L), 11 mm Drill Length EUDAMED
- Device Name
- Drill EUDAMED
- Model / Reference
- Drill EUDAMEDDI0SK00063 EUDAMEDDI0SK00061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874672447 EUDAMED04719874672423 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 & E System Twist Drill, 2 mm (D) x 13 mm (L), 14 mm Drill Length by INTAI Technology Corp. — Class IIa — MDR — listed in EUDAMED
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 (2)
- EUDAMED 015b7ad6-9e2a-4d12-a1e8-468c2014e65b 61 fields · synced Oct 5, 2026
- EUDAMED f61d9cb2-b765-4687-8b65-ed5912d08105 61 fields · synced May 18, 2026