Rose Interdental Brush
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Rose Interdental Brush EUDAMEDMorelli FDA UDI
- Generic Name
- Basic manual toothbrush FDA UDI
- Device Name
- Rose Interdental Brush FDA UDI
- Model / Reference
- ORAL HYGIENE PRODUCTS EUDAMED78.01.004 EUDAMEDFDA UDI
- Description
- Rose Interdental Brush FDA UDI
Identifiers
- Catalog Number
- 78.01.004 FDA UDI
- Primary DI / UDI-DI
- 07895742204198 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742134G3 EUDAMEDB-07895742204198 EUDAMED
- FDA Product Code
- EFW FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Basic manual toothbrush FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6855 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental material injection cannula, single-use
Rose Interdental Brush by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742134G3 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742134G3 | 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 bf8a450c-4c66-4234-bb4d-0d9f3a5d10eb 61 fields · synced Jul 31, 2026
- EUDAMED cbc44f7e-aeb9-402b-9536-6368196245ba 61 fields · synced May 19, 2026
- FDA UDI c3c28720-5557-4c4c-9fed-5cd8ca904201 35 fields · synced May 30, 2026