Identity
- Trade Name
- CORE D Guide KIT EUDAMED
- Device Name
- CORE D Guide KIT EUDAMED
- Model / Reference
- CORE D Guide KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800023124910 EUDAMED
- Basic UDI-DI
- 88000231DntSurgicaIns1GW EUDAMED
- EMDN Code
- L160201 DENTAL MIRRORS AND HANDLES, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
CORE D Guide KIT by Cybermed Inc. — Class I — 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 | 88000231DntSurgicaIns1GW | Class I | Active |
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Manufacturer
- Manufacturer
- Cybermed Inc.,
- EUDAMED SRN
- KR-MF-000009356
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED c80d491a-edee-4fce-82e0-d0df601ab365 61 fields · synced Jun 18, 2026