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Disposable Tray - Upper / Lower Pair - M
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.153Model SINGLE USE INSTRUMENTS
Identity
- Trade Name
- Disposable Tray - Upper / Lower Pair - M EUDAMEDMorelli FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Disposable Tray - Upper / Lower Pair - M FDA UDI
- Model / Reference
- SINGLE USE INSTRUMENTS EUDAMED75.01.153 EUDAMEDFDA UDI
- Description
- Disposable Tray - Upper / Lower Pair - M FDA UDI
Identifiers
- Catalog Number
- 75.01.153 FDA UDI
- Primary DI / UDI-DI
- 07895742245559 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742181GC EUDAMEDB-07895742245559 EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 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
Disposable Tray - Upper / Lower Pair - M 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 | 7895742181GC | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742181GC | 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 c5ab6cfc-a9d1-484f-8077-550ee3e3075c 61 fields · synced Jul 31, 2026
- EUDAMED 9463f420-0b2d-495f-aa2e-c89d6d4b877a 61 fields · synced May 19, 2026
- FDA UDI 58c4923f-614d-408b-ae13-f3064edba744 35 fields · synced May 30, 2026