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Ultrasonic Irrigation Activator
EUDAMEDClass IIa (EU MDR)
Ref N/AModel Ultra Dancer
Identity
- Trade Name
- Ultrasonic Irrigation Activator EUDAMEDUltra Dancer EUDAMED
- Device Name
- Ultrasonic Irrigation Activator EUDAMED
- Model / Reference
- Ultra Dancer EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200999088 EUDAMED
- Basic UDI-DI
- 697590932UIAXA EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
Category: Dental delivery system
Ultrasonic Irrigation Activator by Shanwei Perfect Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697590932UIAXA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanwei Perfect Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000033003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 8596e973-df88-4875-81ad-76496f3ecc71 61 fields · synced Jul 9, 2026
- EUDAMED 83561575-74ec-44b3-80c2-bb7b04d7fe5c 61 fields · synced Jul 9, 2026