Identity
- Trade Name
- Lunos Fluoridgel EUDAMED
- Device Name
- Fluoridgel Erw. Fachanwender EUDAMED
- Model / Reference
- 006300 EUDAMEDPL-0025 EUDAMEDPL-0024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637006703 EUDAMED04099637006680 EUDAMED
- Basic UDI-DI
- B-04099637006703 EUDAMEDB-04099637006680 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lunos Fluoridgel by Hager & Werken GmbH & Co. KG — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04099637006703 | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (2)
- EUDAMED 4e8197a3-15bc-40dd-99bd-3a1f1c07cc4c 61 fields · synced Oct 6, 2026
- EUDAMED c22299c4-e2d6-494e-a77d-362c7f7bda27 61 fields · synced May 18, 2026