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Elastic Chain Long Pearl Blue - 1, 5m
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.05.301Model ELASTIC CHAIN
Identity
- Trade Name
- Elastic Chain Long Pearl Blue - 1,5m EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Elastic Chain Long Pearl Blue - 1,5m FDA UDI
- Model / Reference
- ELASTIC CHAIN EUDAMED60.05.301 EUDAMEDFDA UDI
- Description
- Elastic Chain Long Pearl Blue - 1,5m FDA UDI
Identifiers
- Catalog Number
- 60.05.301 FDA UDI
- Primary DI / UDI-DI
- 07895742258764 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742258764 EUDAMED7895742177GM EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic archwire/bracket ligature 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
Category: Orthodontic retainer
Elastic Chain Long Pearl Blue - 1, 5m 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 Orthodontic retainer.
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- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
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-07895742258764 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742258764 | 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 83923dbd-547e-466f-b478-fd4f45af65ab 61 fields · synced Jun 19, 2026
- EUDAMED fad3ac1e-53bf-423e-98e4-0fd164b4fdba 61 fields · synced May 19, 2026
- FDA UDI 1f61e376-2f04-4f05-b448-1fb6bdccf9f6 35 fields · synced May 29, 2026