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E-System Twist Drill, 3 mm (D) x 8.5-15 mm (L)
EUDAMEDClass IIa (EU MDR)
Ref DI0SK20004Model DrillRef DI0SK20003
Identity
- Trade Name
- E-System Twist Drill, 3 mm (D) x 8.5-15 mm (L) EUDAMEDaZure E-System Twist Drill, 4.3 mm (D) x 8.5-15 mm (L) EUDAMED
- Device Name
- Drill EUDAMED
- Model / Reference
- Drill EUDAMEDDI0SK20004 EUDAMEDDI0SK20003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874672621 EUDAMED04719874672614 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
E-System Twist Drill, 3 mm (D) x 8.5-15 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 (2)
- EUDAMED 16e689de-de55-4ccc-be59-6ffb3729392d 61 fields · synced Sep 17, 2026
- EUDAMED ff9bc5c7-28df-494e-902f-8841842a639e 61 fields · synced May 19, 2026