← Back to catalogue
Ortho-Care Alginate
EUDAMEDClass I (EU MDR)
Ref 9001-IE002Model Orthodontic Alginate
Identity
- Trade Name
- Ortho-Care Alginate EUDAMED
- Device Name
- Orthodontic Alginate EUDAMED
- Model / Reference
- Orthodontic Alginate EUDAMED9001-IE002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600220 EUDAMED
- Basic UDI-DI
- 50563346ALGINATESUIJK EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES 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
Ortho-Care Alginate 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 | 50563346ALGINATESUIJK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Care (UK) Limited
- EUDAMED SRN
- GB-MF-000010884
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 783d2685-7cbc-475b-8422-ea51224fa917 61 fields · synced Jun 17, 2026