Identity
- Trade Name
- OrthoCare Aligner Remover tool EUDAMED
- Device Name
- OrthoCare Aligner Remover tool EUDAMED
- Model / Reference
- 9001-ART02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600251 EUDAMED05056334600985 EUDAMED
- Basic UDI-DI
- 50563346ALIGNERREMRUIL5 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
OrthoCare Aligner Remover tool by Ortho-Care (UK) Limited — Class I — 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 | 50563346ALIGNERREMRUIL5 | Class I | Active |
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Manufacturer
- Manufacturer
- Ortho-Care (UK) Limited
- EUDAMED SRN
- GB-MF-000010884
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED 5857f378-f327-4f00-b420-661db49b2f6e 61 fields · synced Jul 11, 2026
- EUDAMED c4be2c6d-70da-4548-bc80-4fc4cac0984a 61 fields · synced May 18, 2026