Identity
- Trade Name
- FROGGYMOUTH EUDAMED
- Device Name
- Froggymouth EUDAMED
- Model / Reference
- FM2017-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020010163 EUDAMED
- Basic UDI-DI
- 37700200FROGGYDM EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Froggymouth by Biotech Dental Smilers — 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 | 37700200FROGGYDM | Class I | Active |
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Manufacturer
- Manufacturer
- Biotech Dental Smilers
- EUDAMED SRN
- FR-MF-000047137
Sources (1)
- EUDAMED 602da3ae-c4ba-407d-89bb-1a0efe42ab1d 61 fields · synced Jun 19, 2026