Identity
- Trade Name
- iTOOL EUDAMED
- Device Name
- Surgical Drill Bit EUDAMED
- Model / Reference
- AO3012001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16957277201665 EUDAMED
- Basic UDI-DI
- B-16957277201665 EUDAMED
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iTOOL by Apex (Guangzhou) Tools & Orthopedics Co. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16957277201665 | Class IIa | Unknown |
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Manufacturer
- Manufacturer
- Apex (Guangzhou) Tools & Orthopedics Co.
- EUDAMED SRN
- CN-MF-000018403
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED c1707c74-0e6b-4d87-98a4-63d18de21b3c 61 fields · synced Jun 12, 2026