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Spark Unlimited - Refinement
EUDAMEDClass IIa (EU MDR)
Ref 728-3210-SModel 728-*
Identity
- Trade Name
- SPARK UNLIMITED - REFINEMENT EUDAMED
- Device Name
- SPARK * EUDAMED
- Model / Reference
- 728-* EUDAMED728-3210-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989088618 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 Unlimited - Refinement 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 f5d23fb7-d536-4f68-bb6a-52b15bbcd9b7 61 fields · synced Jun 18, 2026