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Impression tray, small upper yellow
EUDAMEDClass I (EU MDR)
Ref 150-301Model Orthodontic Impression Trays
Identity
- Trade Name
- Impression tray, small upper yellow EUDAMED
- Device Name
- Orthodontic Impression Trays EUDAMED
- Model / Reference
- Orthodontic Impression Trays EUDAMED150-301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600268 EUDAMED
- Basic UDI-DI
- 50563346IMPRESSIONSUIJW EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Category: Dental impression tray, single-use
Impression tray, small upper yellow by Ortho-Care (UK) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 50563346IMPRESSIONSUIJW | 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 4fa88371-26d7-40d7-996a-ed872d72dc57 61 fields · synced Jul 9, 2026