Identity
- Model / Reference
- ISE-170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800029600630 EUDAMED
- Basic UDI-DI
- B-08800029600630 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Ise-170 by MICRO-NX Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800029600630 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MICRO-NX Co., Ltd.
- EUDAMED SRN
- KR-MF-000026311
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 83ed59fb-2819-4bd5-8c47-642177103ac7 61 fields · synced Aug 1, 2026