Disposable Tray - Upper / Lower Pair - L
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Disposable Tray - Upper / Lower Pair - L EUDAMEDMorelli FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Disposable Tray - Upper / Lower Pair - L FDA UDI
- Model / Reference
- SINGLE USE INSTRUMENTS EUDAMED75.01.154 EUDAMEDFDA UDI
- Description
- Disposable Tray - Upper / Lower Pair - L FDA UDI
Identifiers
- Catalog Number
- 75.01.154 FDA UDI
- Primary DI / UDI-DI
- 07895742245566 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742245566 EUDAMED7895742181GC 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
Single Use
Yes
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
Yes
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 impression tray, single-use
Disposable Tray - Upper / Lower Pair - L by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742245566 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742245566 | 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 f29cd7d3-3e9f-4fb9-a231-164391daf226 61 fields · synced Jul 30, 2026
- EUDAMED dba994ab-e6da-4f46-bbb8-2ea439415c49 61 fields · synced May 18, 2026
- FDA UDI b7208c9d-747a-418e-b382-a70bb74aafa8 35 fields · synced May 30, 2026