Identity
- Trade Name
- Dental Oral irrigator EUDAMED
- Device Name
- Dental Oral irrigator EUDAMED
- Model / Reference
- LD-A3，LD-A8，LD-A9 EUDAMEDLD-A8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384254129 EUDAMED
- Basic UDI-DI
- 697038425DOIR3 EUDAMED
- EMDN Code
- Z12119006 DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Dental Oral irrigator by HONSUN (NANTONG) Co., Ltd. — 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 | 697038425DOIR3 | Class I | Active |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009428
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 53ec3d85-97c1-46f1-b210-1d6db0b56c9a 61 fields · synced Jun 18, 2026