Identity
- Trade Name
- MyoSimple EUDAMED
- Device Name
- MyoSimple EUDAMED
- Model / Reference
- MYOSIMPLE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020010248 EUDAMED
- Basic UDI-DI
- B-03770020010248 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
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
MyoSimple by Biotech Dental Smilers — 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-03770020010248 | Class I | Active |
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Manufacturer
- Manufacturer
- Biotech Dental Smilers
- EUDAMED SRN
- FR-MF-000047137
Sources (2)
- EUDAMED 93671a56-05b1-482d-9dab-e1b01c677b34 61 fields · synced Jul 14, 2026
- EUDAMED 26a7dcb6-3e8d-4553-a22c-137e8117bde1 61 fields · synced Jul 14, 2026