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Mini Hyrax - 11 mm Opening (9mm Expansion)
EUDAMEDClass IIa (EU MDR)
Ref 65.05.112Model ORTHODONTIC EXPANDER
Identity
- Trade Name
- Mini Hyrax - 11 mm Opening (9mm Expansion) EUDAMED
- Model / Reference
- ORTHODONTIC EXPANDER EUDAMED65.05.112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07895742292232 EUDAMED
- Basic UDI-DI
- 7895742173GD EUDAMEDB-07895742292232 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
Mini Hyrax - 11 mm Opening (9mm Expansion) 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 507cb673-fd60-4fda-b43f-f9e7c8a7432c 61 fields · synced Jun 19, 2026
- EUDAMED 83e44f07-8615-4073-b4cc-9dd0b64e4aa2 61 fields · synced May 19, 2026