Identity
- Trade Name
- Waterpik Densco Proflex Flexible Scaler EUDAMED
- Device Name
- Manual Dental Scaler EUDAMED
- Model / Reference
- 085000-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D6860850003 EUDAMED
- Basic UDI-DI
- ++D68638796NU EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, 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 Densco Proflex Flexible Scaler 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 | ++D68638796NU | 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 7c89a680-960c-46cf-98a9-d53092da034f 61 fields · synced Jun 19, 2026