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Expansion Screw Palatal Split - Opening 11mm
EUDAMEDClass IIa (EU MDR)
Ref 65.05.012Model ORTHODONTIC EXPANDER
Identity
- Trade Name
- Expansion Screw Palatal Split - Opening 11mm EUDAMED
- Model / Reference
- ORTHODONTIC EXPANDER EUDAMED65.05.012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07895742005672 EUDAMED
- Basic UDI-DI
- B-07895742005672 EUDAMED7895742173GD 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 11mm by Dental Morelli Ltda. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742005672 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742005672 | 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 2703f455-03df-4911-9799-028a85080a76 61 fields · synced Jun 18, 2026
- EUDAMED 7d1b81ed-01ed-4330-bddb-e4e3ec49ac7b 61 fields · synced May 19, 2026