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DIOnavi. Initial Positioning Drill
EUDAMEDClass IIa (EU MDR)
Ref DIO Implant System Product Catalog Ver 7.0 (KR)Model SGPD 38
Identity
- Trade Name
- DIOnavi. Initial Positioning Drill EUDAMED
- Device Name
- DIO Master S Kit, DIOnavi. Profile Drill, UF(II) Guide Side Cut Drill, DIOnavi. Initial Positioning Dril, Deep Bone Flattening Drill, UF(II) Narrow Surgical Kit, DIOnavi. Straight Drill, DIO New Dr. SOS+ Kit, UF(II) Starter Kit, and 1 additional item EUDAMED
- Model / Reference
- SGPD 38 EUDAMEDDIO Implant System Product Catalog Ver 7.0 (KR) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800049480373 EUDAMED
- Basic UDI-DI
- 880004925043BG EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
DIOnavi. Initial Positioning Drill by DIO Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 880004925043BG | Class IIa | Active |
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Manufacturer
- Manufacturer
- DIO Corporation
- EUDAMED SRN
- KR-MF-000008515
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED f2ceefec-6395-41b8-8c86-f7ed82142a34 61 fields · synced Jul 8, 2026