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Spark Junior (phase 1) - Dual Arch
EUDAMEDClass IIa (EU MDR)
Ref 728-3220-DModel 728-*
Identity
- Trade Name
- SPARK JUNIOR (PHASE 1) - DUAL ARCH EUDAMED
- Device Name
- SPARK * EUDAMED
- Model / Reference
- 728-* EUDAMED728-3220-D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989088670 EUDAMED
- Basic UDI-DI
- 0889989-Sprk_Clr_Align-48 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Spark Junior (phase 1) - Dual Arch by Ormco Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-Sprk_Clr_Align-48 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (1)
- EUDAMED 8b6b8376-d8a2-4ea3-aab9-4e82104e12f4 61 fields · synced Jul 29, 2026