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Orthodontic Impression Trays
EUDAMEDClass I (EU MDR)
Ref 150-002Model Orthodontic Impression TraysRef 150-001Ref 150-302Ref 150-305Ref 150-306Ref 150-304Ref 150-303
Identity
- Device Name
- Orthodontic Impression Trays EUDAMED
- Model / Reference
- Orthodontic Impression Trays EUDAMED150-002 EUDAMED150-001 EUDAMED150-302 EUDAMED150-305 EUDAMED150-306 EUDAMED150-304 EUDAMED150-303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600336 EUDAMED05056334600329 EUDAMED05056334600275 EUDAMED05056334600305 EUDAMED05056334600312 EUDAMED05056334600299 EUDAMED05056334600282 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
Orthodontic Impression Trays by Ortho-Care (UK) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
- Miratray Partiell PR 100er — Hager & Werken GmbH & Co. KG · Class I
- COE® — Gc America Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- EXCELLENT — PLASDENT CORP. · Class I
- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · Class I
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 (7)
- EUDAMED e9c76d49-fcf7-4fab-8cff-624fea38f0cd 61 fields · synced Sep 18, 2026
- EUDAMED ae219d98-4142-4884-9947-9962effd190f 61 fields · synced May 17, 2026
- EUDAMED b3ea870b-0145-4875-a1f3-9f0829ddd2e8 61 fields · synced May 17, 2026
- EUDAMED 8d63be27-64a6-4886-abae-bca940488010 61 fields · synced May 18, 2026
- EUDAMED f40f243f-0e30-40ef-aded-9420b076df7c 61 fields · synced May 18, 2026
- EUDAMED 03e9ce3d-6f23-4f58-ad92-c8d7984238ce 61 fields · synced May 19, 2026
- EUDAMED 0138c3a1-0a88-482f-a123-41540f0577e7 61 fields · synced May 19, 2026