← Back to catalogue
Lip Bumper with Hook - Pink - Ø1, 15mm (.045")
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50.50.007Model THREADS AND BOWS - Class I
Identity
- Trade Name
- Lip Bumper with Hook - Pink - Ø1,15mm (.045") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic clasp, metal, preformed FDA UDI
- Device Name
- Lip Bumper with Hook - Pink - Ø1,15mm (.045") FDA UDI
- Model / Reference
- THREADS AND BOWS - Class I EUDAMED50.50.007 EUDAMEDFDA UDI
- Description
- Lip Bumper with Hook - Pink - Ø1,15mm (.045") FDA UDI
Identifiers
- Catalog Number
- 50.50.007 FDA UDI
- Primary DI / UDI-DI
- 07895742006570 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742130FT EUDAMEDB-07895742006570 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic clasp, metal, preformed 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
Lip Bumper with Hook - Pink - Ø1, 15mm (.045") 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 | 7895742130FT | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742130FT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED 52130fd2-4a96-414e-b91a-49c72cf2c78a 61 fields · synced Jun 19, 2026
- EUDAMED 537cee5b-4ae2-48ac-abe1-59ebccbc7dd4 61 fields · synced May 19, 2026
- FDA UDI 4cae4415-08f3-44a5-84e0-1e2f1a6b903f 35 fields · synced May 29, 2026