Identity
- Trade Name
- Waterpik Master Tray Impression Tray EUDAMED
- Device Name
- Dental Impression Tray EUDAMED
- Model / Reference
- 011201-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D6860112015003 EUDAMED
- Basic UDI-DI
- ++D68616350LC EUDAMED
- Unit of Use DI
- D6860112015000 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
Waterpik Master Tray Impression Tray by Water Pik, Inc. — 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 | ++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 (1)
- EUDAMED 685fe657-a55c-466c-abe2-b1ac4d8b8e7d 61 fields · synced Jun 18, 2026