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Kp-E0-19, Kp-E1-31, Kp-E2-31, Kp-E3-31, Kp-E4-31, Kp-E5-31
EUDAMEDClass IIa (EU MDR)
Ref /Model KP,DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E
Identity
- Trade Name
- KP-E0-19,KP-E1-31,KP-E2-31, KP-E3-31,KP-E4-31,KP-E5-31 EUDAMED
- Device Name
- Root Canal File EUDAMED
- Model / Reference
- KP,DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975384336769 EUDAMED
- Basic UDI-DI
- 69753843302YN EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE 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
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
Kp-E0-19, Kp-E1-31, Kp-E2-31, Kp-E3-31, Kp-E4-31, Kp-E5-31 by Guilin Kevin Peter Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 69753843302YN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guilin Kevin Peter Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022934
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED ef43e111-12ef-4e93-8235-e3a36b3f5dbe 61 fields · synced Jun 19, 2026