Identity
- Trade Name
- Aligner Chews EUDAMED
- Device Name
- Aligner Chews EUDAMED
- Model / Reference
- Aligner Chews EUDAMED9001-AC-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600244 EUDAMED
- Basic UDI-DI
- 50563346ALIGNERCHEWRUIMA EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Aligner Chews 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 | 50563346ALIGNERCHEWRUIMA | Class I | Active |
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Manufacturer
- Manufacturer
- Ortho-Care (UK) Limited
- EUDAMED SRN
- GB-MF-000010884
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 66ed358d-3a29-431c-aa92-fdc98135d6ab 61 fields · synced Jun 18, 2026