Identity
- Trade Name
- MDK HANDPIECES EUDAMED
- Device Name
- ELECTRICAL AIR DRIVEN DENTAL HAND PIECE EUDAMED
- Model / Reference
- MOKO 320K LED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027300266 EUDAMED
- Basic UDI-DI
- B-08800027300266 EUDAMED
- EMDN Code
- L030199 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Mdk Handpieces by Mdk 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-08800027300266 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mdk Co., Ltd.
- EUDAMED SRN
- KR-MF-000042246
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 43d27f96-2b4a-458a-91b7-dd597375df3c 61 fields · synced May 23, 2026