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Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.007Model REUSABLE INSTRUMENTS
Identity
- Trade Name
- Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic elastomeric appliance pusher FDA UDI
- Device Name
- Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm FDA UDI
- Model / Reference
- REUSABLE INSTRUMENTS EUDAMED75.01.007 EUDAMEDFDA UDI
- Description
- Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm FDA UDI
Identifiers
- Catalog Number
- 75.01.007 FDA UDI
- Primary DI / UDI-DI
- 07895742002749 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742133FZ EUDAMEDB-07895742002749 EUDAMED
- FDA Product Code
- ECR FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthodontic elastomeric appliance pusher FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Dry Heat Sterilization FDA UDI
Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742133FZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742133FZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 97e841f4-4d72-4e82-8155-95a15bccb075 61 fields · synced Jun 19, 2026
- EUDAMED ea7be66a-db82-4211-bf2e-ccf136c69baf 61 fields · synced May 19, 2026
- FDA UDI 71e2fb8f-c03c-4830-891f-a354fbd880c9 35 fields · synced May 30, 2026