Identity
- Trade Name
- Ultrasonic Scaler EUDAMED
- Device Name
- Ultrasonic Scaler EUDAMED
- Model / Reference
- PT 6, PT6 PRO EUDAMEDPT6 PRO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971560450229 EUDAMED
- Basic UDI-DI
- 697156045PT6S7 EUDAMED
- Direct Marketing DI
- 06971560450229 EUDAMED
- EMDN Code
- Z12119001 TARTAR ABLATORS 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 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 | 697156045PT6S7 | 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 39ace085-a240-44b5-99f5-4c946fea862b 61 fields · synced May 23, 2026