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Stop and Bite Guide
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30.60.001Model STOP AND BITE GUIDE
Identity
- Trade Name
- Stop and Bite Guide EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic clasp, metal, preformed FDA UDI
- Device Name
- Stop and Bite Guide FDA UDI
- Model / Reference
- STOP AND BITE GUIDE EUDAMED30.60.001 EUDAMEDFDA UDI
- Description
- Stop and Bite Guide FDA UDI
Identifiers
- Catalog Number
- 30.60.001 FDA UDI
- Primary DI / UDI-DI
- 07895742166069 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742166069 EUDAMED7895742185GL 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
Stop and Bite Guide 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-07895742166069 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742166069 | 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 f2e78b89-867d-40cf-b514-be734d3b5e9e 61 fields · synced Jul 30, 2026
- FDA UDI fd432c2d-5f3d-4c90-94c4-c4eaf6ba6841 35 fields · synced May 30, 2026
- EUDAMED 5b233e9f-bac5-4cc9-bd63-ba2e1b343a45 61 fields · synced Jul 8, 2026