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Ultrasonic Scaler Handpiece
EUDAMEDClass IIa (EU MDR)
Ref HP-3HRef HP-5LRef HS-7L
Identity
- Device Name
- Ultrasonic Scaler Handpiece EUDAMED
- Model / Reference
- HP-3H EUDAMEDHP-5L EUDAMEDHS-7L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971560450373 EUDAMED06971560453282 EUDAMED06971560453299 EUDAMED
- Basic UDI-DI
- B-06971560450373 EUDAMEDB-06971560453282 EUDAMEDB-06971560453299 EUDAMED
- EMDN Code
- Z12119006 DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultrasonic Scaler Handpiece by Guilin Refine Medical Instrument Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971560450373 | 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 (3)
- EUDAMED d19b35ea-e51c-4edd-b6da-4e659823f8a0 61 fields · synced Oct 6, 2026
- EUDAMED 28744062-5a39-4d7b-9d3c-c46d601cfd73 61 fields · synced May 18, 2026
- EUDAMED 109cf4f3-b979-4402-a050-6b8181feadf7 61 fields · synced May 19, 2026