Identity
- Trade Name
- Fluoride Varnish EUDAMED
- Device Name
- Fluoride Varnish EUDAMED
- Model / Reference
- Type III EUDAMED09503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974998831097 EUDAMED
- Basic UDI-DI
- 6974998830903MJ EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
Fluoride Varnish by Chengdu I-ReHealth Medical Devices 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 | 6974998830903MJ | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu I-ReHealth Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000019445
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED f5a58eed-390e-47f6-b597-e5f00f9a1323 61 fields · synced Oct 6, 2026