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Mini Spur Tongue Educator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30.60.002Model MINI SPORON
Identity
- Trade Name
- Mini Spur Tongue Educator EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic clasp, metal, preformed FDA UDI
- Device Name
- Mini Spur Tongue Educator FDA UDI
- Model / Reference
- MINI SPORON EUDAMED30.60.002 EUDAMEDFDA UDI
- Description
- Mini Spur Tongue Educator FDA UDI
Identifiers
- Catalog Number
- 30.60.002 FDA UDI
- Primary DI / UDI-DI
- 07895742197810 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742197810 EUDAMED7895742184GJ EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic clasp, metal, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Mini Spur Tongue Educator by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742197810 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742197810 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED d5e4344b-b9e0-40c0-b520-a4346b152d4a 61 fields · synced Jul 19, 2026
- FDA UDI d19e49af-a037-4dd3-9afb-f3b6607c9546 35 fields · synced May 29, 2026
- EUDAMED 49da0dc2-645b-4fb8-8ec5-48fe9f3e50d6 61 fields · synced Jul 8, 2026