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Large Lip Retractor
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.046Model LIP REMOVER
Identity
- Trade Name
- Large Lip Retractor EUDAMEDMorelli FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- Large Lip Retractor FDA UDI
- Model / Reference
- LIP REMOVER EUDAMED75.01.046 EUDAMEDFDA UDI
- Description
- Large Lip Retractor FDA UDI
Identifiers
- Catalog Number
- 75.01.046 FDA UDI
- Primary DI / UDI-DI
- 07895742101176 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742101176 EUDAMED7895742189GU EUDAMED
- FDA Product Code
- EIG FDA UDI
- EMDN Code
- L150202 BUCCAL SPREADERS, REUSABLE EUDAMED
- GMDN Term
- Dental cheek retractor, professional, reusable 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
Large Lip Retractor 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-07895742101176 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742101176 | 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 3d667972-a690-4cd4-bb1a-926a60ade5b4 61 fields · synced Jul 15, 2026
- EUDAMED c61386af-561c-44a3-94fe-903ef5bf6138 61 fields · synced May 19, 2026
- FDA UDI f168f10f-287a-411a-a278-db73c4ee86a6 35 fields · synced May 30, 2026