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Spark Junior (phase 1) - Single Arch
EUDAMEDClass IIa (EU MDR)
Ref 728-3220-AModel 728-*
Identity
- Trade Name
- SPARK JUNIOR (PHASE 1) - SINGLE ARCH EUDAMED
- Device Name
- SPARK * EUDAMED
- Model / Reference
- 728-* EUDAMED728-3220-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989088663 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) - Single 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 ec4d6148-978a-41a3-baba-8f0b4297ae2b 61 fields · synced Jun 18, 2026