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Tube for Activator with Bar Ø1, 15mm (.045")
EUDAMEDFDA UDIClass I (EU MDR)
Ref 30.05.145Model ACCESSORIES - Class I
Identity
- Trade Name
- Tube for Activator with Bar Ø1,15mm (.045") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic lock FDA UDI
- Device Name
- Tube for Activator with Bar Ø1,15mm (.045") FDA UDI
- Model / Reference
- ACCESSORIES - Class I EUDAMED30.05.145 EUDAMEDFDA UDI
- Description
- Tube for Activator with Bar Ø1,15mm (.045") FDA UDI
Identifiers
- Catalog Number
- 30.05.145 FDA UDI
- Primary DI / UDI-DI
- 07895742008727 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742008727 EUDAMED7895742129GA EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic lock FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 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
Tube for Activator with Bar Ø1, 15mm (.045") 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-07895742008727 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742008727 | 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 01775db2-24f9-4df8-aa5d-7a2cce6b589f 61 fields · synced Jul 9, 2026
- EUDAMED dc50b3b7-6611-4a9c-8b98-32828ac5618f 61 fields · synced May 19, 2026
- FDA UDI 006d83a5-4328-4416-b649-70782494a600 35 fields · synced May 30, 2026