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Waterpik Sani-Trays Impression Tray
EUDAMEDClass I (EU MDR)
Ref 011516-012Ref 011517-012Ref 011511-012Ref 011514-012Ref 011521-012Ref 011518-012Ref 011513-012Ref 011515-012Ref 011524-012Ref 011522-012
Identity
- Trade Name
- Waterpik Sani-Trays Impression Tray EUDAMED
- Device Name
- Dental Impression Tray EUDAMED
- Model / Reference
- 011516-012 EUDAMED011517-012 EUDAMED011511-012 EUDAMED011514-012 EUDAMED011521-012 EUDAMED011518-012 EUDAMED011513-012 EUDAMED011515-012 EUDAMED011524-012 EUDAMED011522-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D6860115160123 EUDAMEDD6860115170123 EUDAMEDD6860115110123 EUDAMEDD6860115140123 EUDAMEDD6860115210123 EUDAMEDD6860115180123 EUDAMEDD6860115130123 EUDAMEDD6860115150123 EUDAMEDD6860115240123 EUDAMEDD6860115220123 EUDAMED
- Basic UDI-DI
- ++D68616350LC EUDAMED
- Unit of Use DI
- D6860115160120 EUDAMEDD6860115170120 EUDAMEDD6860115110120 EUDAMEDD6860115140120 EUDAMEDD6860115210120 EUDAMEDD6860115180120 EUDAMEDD6860115130120 EUDAMEDD6860115150120 EUDAMEDD6860115240120 EUDAMEDD6860115220120 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
Waterpik Sani-Trays Impression Tray by Water Pik, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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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 | ++D68616350LC | Class I | Active |
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Manufacturer
- Manufacturer
- Water Pik, Inc.
- EUDAMED SRN
- US-MF-000017734
- Authorised Representative
- Sofibel FR-AR-000003191
Sources (10)
- EUDAMED 359f903c-f02d-43d2-97db-b04a0abbb85a 61 fields · synced Sep 30, 2026
- EUDAMED 21b24fb3-26d1-46af-8e76-eeecf1f2360f 61 fields · synced May 16, 2026
- EUDAMED 5d5babb6-5481-4593-95eb-2026a5bd7aaa 61 fields · synced May 16, 2026
- EUDAMED 461e2833-6f90-4770-9325-65d149cd1444 61 fields · synced May 17, 2026
- EUDAMED a6f5beff-90cf-45c9-b675-f20e06dca748 61 fields · synced May 17, 2026
- EUDAMED dbc0f872-85ce-4806-9d92-7811aafdc598 61 fields · synced May 18, 2026
- EUDAMED dcbcdade-eafe-4013-8003-4d9a30fef744 61 fields · synced May 18, 2026
- EUDAMED 456422b5-cfc4-423c-9713-18ef95f647df 61 fields · synced May 18, 2026
- EUDAMED f7196937-e2b4-4557-98aa-432da4409f73 61 fields · synced May 18, 2026
- EUDAMED 0d6168a9-9e21-42d1-91f8-6abe9733985b 61 fields · synced May 18, 2026