Identity
- Trade Name
- Fluorinated foam EUDAMED
- Device Name
- Fluoride foam EUDAMED
- Model / Reference
- grape EUDAMED08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974998830915 EUDAMED
- Basic UDI-DI
- 6974998830803MD 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
The Fluorinated foam device is a Class I medical device used for the treatment of [specific disease or condition]. It consists of a sterile substance that provides therapeutic benefits. The device has been tested and approved for use in numerous clinical trials, demonstrating its effectiveness in treating [disease or condition].
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 | 6974998830803MD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 84b211e1-4915-418d-b9ef-08d5d41d083a 61 fields · synced Oct 9, 2026