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Headgear for Safety Breakaway Device - Size Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref 70.31.003Model AUXILIARY ORTHODONTIC COMPONENTS
Identity
- Trade Name
- Headgear for Safety Breakaway Device - Size Large EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Headgear for Safety Breakaway Device - Size Large FDA UDI
- Model / Reference
- AUXILIARY ORTHODONTIC COMPONENTS EUDAMED70.31.003 EUDAMEDFDA UDI
- Description
- Headgear for Safety Breakaway Device - Size Large FDA UDI
Identifiers
- Catalog Number
- 70.31.003 FDA UDI
- Primary DI / UDI-DI
- 07895742001520 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742132FX EUDAMEDB-07895742001520 EUDAMED
- FDA Product Code
- KCR FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3220 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
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
Headgear for Safety Breakaway Device - Size Large by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7895742132FX | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742132FX | 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 aebcd669-2719-40b5-8f13-7c408f10cec8 61 fields · synced Aug 1, 2026
- EUDAMED 31ef8435-59d0-470f-b9ef-a1346165a8c1 61 fields · synced May 19, 2026
- FDA UDI 05c6a42f-2e90-4688-9d84-7eb43855268f 35 fields · synced May 29, 2026