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aZure E-system Final Implant Drill, 4.5 mm (D) x 8.5 mm (L)

EUDAMED

Class IIa (EU MDR)

Ref DI0SK20034Model DrillRef DI0SK20036Ref DI0SK20038

by INTAI Technology Corp.

Identity

Trade Name
aZure E-system Final Implant Drill, 4.5 mm (D) x 8.5 mm (L) EUDAMED
aZure E-system Final Implant Drill, 4.5 mm (D) x 11.5 mm (L) EUDAMED
aZure E-system Final Implant Drill, 4.5 mm (D) x 15 mm (L) EUDAMED
Device Name
Drill EUDAMED
Model / Reference
Drill EUDAMED
DI0SK20034 EUDAMED
DI0SK20036 EUDAMED
DI0SK20038 EUDAMED

Identifiers

Primary DI / UDI-DI
04719874673581 EUDAMED
04719874673604 EUDAMED
04719874673628 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 Final Implant Drill, 4.5 mm (D) x 8.5 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 c8b8a6cc-bc95-498d-99b5-48a48fea6658 61 fields · synced Jul 16, 2026
  • EUDAMED f4605bfc-fc30-4f7b-aafe-a7375e6d238e 61 fields · synced May 17, 2026
  • EUDAMED 1f2c359e-2fa4-4b1b-b390-79b61bad889d 61 fields · synced May 19, 2026