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Tongue Cleaner - Blue and Rose
EUDAMEDFDA UDIClass I (EU MDR)
Ref 78.02.001Model ORAL HYGIENE PRODUCTS
Identity
- Trade Name
- Tongue Cleaner - Blue and Rose EUDAMEDMorelli FDA UDI
- Generic Name
- Tongue scraper, reusable FDA UDI
- Device Name
- Tongue Cleaner - Blue and Rose FDA UDI
- Model / Reference
- ORAL HYGIENE PRODUCTS EUDAMED78.02.001 EUDAMEDFDA UDI
- Description
- Tongue Cleaner - Blue and Rose FDA UDI
Identifiers
- Catalog Number
- 78.02.001 FDA UDI
- Primary DI / UDI-DI
- 07895742228293 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742228293 EUDAMED7895742134G3 EUDAMED
- FDA Product Code
- LCN FDA UDI
- EMDN Code
- Q019007 BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Tongue scraper, reusable 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
EUDAMEDFDA UDI
Single Use
No
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
No
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
Tongue Cleaner - Blue and Rose by Dental Morelli Ltda. — Class I — 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-07895742228293 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742228293 | 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 23b130b0-446f-4de0-ae03-4ab617c03edc 61 fields · synced Jul 30, 2026
- EUDAMED 0c8ddc37-3f82-430b-8a35-8697c477538b 61 fields · synced May 17, 2026
- FDA UDI 436a8fd4-2fc1-4552-b66c-f610fa03e737 35 fields · synced May 30, 2026