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I-ReHealth Fluoride Varnish
EUDAMEDClass I (EU MDR)
Ref NAModel 10g/tubeRef 09501Model Type IModel 0.5g/pouchRef 09506Model Type IIIRef 09504
Identity
- Trade Name
- I-ReHealth Fluoride Varnish EUDAMEDFluoride Varnish EUDAMED
- Device Name
- I-ReHealth Fluoride Varnish EUDAMEDFluoride Varnish EUDAMED
- Model / Reference
- 10g/tube EUDAMEDNA EUDAMEDType I EUDAMED09501 EUDAMED0.5g/pouch EUDAMEDType III EUDAMED09506 EUDAMED09504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974998830021 EUDAMED06974998831059 EUDAMED06974998830014 EUDAMED06974998831080 EUDAMED06974998831042 EUDAMED
- Basic UDI-DI
- 6974998830268 EUDAMED6974998830901ME EUDAMED6974998830166 EUDAMED6974998830903MJ 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
I-ReHealth 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 | 6974998830268 | 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 (5)
- EUDAMED 90c19dd1-acf2-4c85-93a2-3fd73cf4f9d4 61 fields · synced Oct 6, 2026
- EUDAMED 9bfefca2-71dc-4e8a-87bd-3823bc3a1082 61 fields · synced May 17, 2026
- EUDAMED f4f7eaaf-de94-4cb8-9c6d-d011aa88c58a 61 fields · synced May 18, 2026
- EUDAMED 51d8d570-1871-4075-8feb-d6f9e13c5105 61 fields · synced May 18, 2026
- EUDAMED f6256d7e-c0d5-40cf-a29d-22a20f090a19 61 fields · synced May 18, 2026