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aZure C-system Final Implant Drill, 3.5 mm (D) x 13 mm (L)

EUDAMED

Class IIa (EU MDR)

Ref DI0SK10021Model DrillRef DI0SK10022Ref DI0SK10020

by INTAI Technology Corp.

Identity

Trade Name
aZure C-system Final Implant Drill, 3.5 mm (D) x 13 mm (L) EUDAMED
aZure C-system Final Implant Drill, 3.5 mm (D) x 15 mm (L) EUDAMED
aZure C-system Final Implant Drill, 3.5 mm (D) x 11.5 mm (L) EUDAMED
Device Name
Drill EUDAMED
Model / Reference
Drill EUDAMED
DI0SK10021 EUDAMED
DI0SK10022 EUDAMED
DI0SK10020 EUDAMED

Identifiers

Primary DI / UDI-DI
04719874673314 EUDAMED
04719874673321 EUDAMED
04719874673307 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, 3.5 mm (D) x 13 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

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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 1ec25edf-3654-46c8-ae97-1c31c674af28 61 fields · synced Aug 3, 2026
  • EUDAMED 9d495bc3-5777-4675-a6a0-f24986e5696d 61 fields · synced May 17, 2026
  • EUDAMED 55216ad7-804d-4dec-add7-20c6137059b0 61 fields · synced May 18, 2026