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Tray Aways
EUDAMEDClass I (EU MDR)
Ref 0921884Ref 0921889Ref 0921897Ref 0921891Ref 0921896Ref 0921887Ref 0921894Ref 0921893Ref 0921886
Identity
- Trade Name
- Tray Aways EUDAMED
- Device Name
- Disposable Impression Trays EUDAMED
- Model / Reference
- 0921884 EUDAMED0921889 EUDAMED0921897 EUDAMED0921891 EUDAMED0921896 EUDAMED0921887 EUDAMED0921894 EUDAMED0921893 EUDAMED0921886 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++H66809218841 EUDAMED++H66809218891 EUDAMED++H66809218971 EUDAMED++H66809218911 EUDAMED++H66809218961 EUDAMED++H66809218871 EUDAMED++H66809218941 EUDAMED++H66809218931 EUDAMED++H66809218861 EUDAMED
- Basic UDI-DI
- ++H668IMPTRAY001DW EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Tray Aways by Keystone Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
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- 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 | ++H668IMPTRAY001DW | Class I | Active |
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Manufacturer
- Manufacturer
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- KEYSTONE Europe BV NL-AR-000010443
Sources (10)
- EUDAMED 7b73bdd1-db29-4eae-8f3d-9d6c7320b8f1 61 fields · synced Aug 5, 2026
- EUDAMED a7a3bd3c-c517-49c2-97f2-79309e206852 61 fields · synced Jul 9, 2026
- EUDAMED aef1ab87-ec4a-4678-a6d5-4d6d249b44c2 61 fields · synced Jul 9, 2026
- EUDAMED 74d119c7-20c5-416d-91a5-6887626286dc 61 fields · synced Jul 16, 2026
- EUDAMED 89bf1b90-ffb6-4b52-b6e5-f5f083612f8a 61 fields · synced Jul 20, 2026
- EUDAMED 58b492ed-8293-4046-b91a-44e77cbd237b 61 fields · synced Jul 23, 2026
- EUDAMED 35e3e20b-a1cd-4f32-b065-7c4dd7c2a1b7 61 fields · synced Jul 24, 2026
- EUDAMED eee7ac0c-cd4c-465b-9e12-4aa36ee1c461 61 fields · synced Aug 1, 2026
- EUDAMED dc0b51ea-7926-41c3-8f40-04bc4bfdfc71 61 fields · synced Aug 4, 2026
- EUDAMED 3c798cea-de85-487c-b889-2ffed3c3f9e3 61 fields · synced Aug 5, 2026