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Expansion Screw Palatal Split - Opening 9mm
EUDAMEDClass IIa (EU MDR)
Ref 65.05.011Model ORTHODONTIC EXPANDER
Identity
- Trade Name
- Expansion Screw Palatal Split - Opening 9mm EUDAMED
- Model / Reference
- ORTHODONTIC EXPANDER EUDAMED65.05.011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07895742005665 EUDAMED
- Basic UDI-DI
- 7895742173GD EUDAMEDB-07895742005665 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
Expansion Screw Palatal Split - Opening 9mm by Dental Morelli Ltda. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742173GD | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7895742173GD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (2)
- EUDAMED 4ab2d689-f668-4cf2-9127-3e89072d3749 61 fields · synced Jun 19, 2026
- EUDAMED 2f919f7c-05e1-4490-b9d5-93e9ac4394cb 61 fields · synced May 19, 2026