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aZure E-system Final Implant Drill, 3.5 mm (D) x 11.5 mm (L)
EUDAMEDClass IIa (EU MDR)
Ref DI0SK20026Model DrillRef DI0SK20028Ref DI0SK20025Ref DI0SK20024
Identity
- Trade Name
- aZure E-system Final Implant Drill, 3.5 mm (D) x 11.5 mm (L) EUDAMEDaZure E-system Final Implant Drill, 3.5 mm (D) x 15 mm (L) EUDAMEDaZure E-system Final Implant Drill, 3.5 mm (D) x 10 mm (L) EUDAMEDaZure E-system Final Implant Drill, 3.5 mm (D) x 8.5 mm (L) EUDAMED
- Device Name
- Drill EUDAMED
- Model / Reference
- Drill EUDAMEDDI0SK20026 EUDAMEDDI0SK20028 EUDAMEDDI0SK20025 EUDAMEDDI0SK20024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874673505 EUDAMED04719874673529 EUDAMED04719874673499 EUDAMED04719874673482 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
Category: Surgical retraction system, reusable
aZure E-system Final Implant Drill, 3.5 mm (D) x 11.5 mm (L) by INTAI Technology Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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 (4)
- EUDAMED 949e13c7-1b27-4aea-8230-fd254d724055 61 fields · synced Jul 23, 2026
- EUDAMED 520006e0-2036-485a-9a26-e85b5ab0afb3 61 fields · synced May 16, 2026
- EUDAMED 010dba39-adb8-4d1b-b4ab-fff3e1d64af6 61 fields · synced May 18, 2026
- EUDAMED bfe7e300-9fe9-44c6-b361-3783265ccec1 61 fields · synced May 19, 2026