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Impression Tray - nr. 07 - upper/lower
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.057Model PRINTING MOLD
Identity
- Trade Name
- Impression Tray - nr. 07 - upper/lower EUDAMEDMorelli FDA UDI
- Generic Name
- Dental impression tray, reusable FDA UDI
- Device Name
- Impression Tray - nr. 07 - upper/lower FDA UDI
- Model / Reference
- PRINTING MOLD EUDAMED75.01.057 EUDAMEDFDA UDI
- Description
- Impression Tray - nr. 07 - upper/lower FDA UDI
Identifiers
- Catalog Number
- 75.01.057 FDA UDI
- Primary DI / UDI-DI
- 07895742086695 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742086695 EUDAMED7895742188GS EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- L150701 ORTHODONTIC LIGATURE TOOLS, REUSABLE EUDAMED
- GMDN Term
- Dental impression tray, reusable 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
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
Impression Tray - nr. 07 - upper/lower 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-07895742086695 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742086695 | 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 19045b54-7550-4d74-a098-6299132a75ce 61 fields · synced Jul 25, 2026
- EUDAMED a241d753-9549-471b-8a51-c26207f643d0 61 fields · synced May 18, 2026
- FDA UDI bdac21f0-26be-4467-89e9-540058e04011 35 fields · synced May 30, 2026