Identity
- Trade Name
- Ultrasonic Scaler Tip EUDAMED
- Device Name
- Ultrasonic Scaler Tip EUDAMED
- Model / Reference
- P14R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971560452636 EUDAMED
- Basic UDI-DI
- 697156045USTUP EUDAMED
- Direct Marketing DI
- 06971560452636 EUDAMED
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Ultrasonic Scaler Tip by Guilin Refine Medical Instrument Co., Ltd. — Class IIa — 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 | 697156045USTUP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012204
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED d6c5140f-f1ed-49bb-bbd6-f6da3d9e96c5 61 fields · synced Jun 18, 2026