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PP UltraLED std Bin(B) (ErgoGrip LightGrey +3 more)
EUDAMEDClass IIa (EU MDR)
Ref 15610961_02Model Ultrasonic device for professional dental care, built-in
Identity
- Trade Name
- PP UltraLED std Bin(B) (ErgoGrip LightGrey,PE-37,PE-39,PE-41PS) EUDAMED
- Model / Reference
- Ultrasonic device for professional dental care, built-in EUDAMED15610961_02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311204215 EUDAMED
- Basic UDI-DI
- B-06438311204215 EUDAMED
- EMDN Code
- Z12119001 TARTAR ABLATORS EUDAMED
- Models / Variants
- ErgoGrip LightGrey EUDAMEDPE-37 EUDAMEDPE-39 EUDAMEDPE-41PS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
PP UltraLED std Bin(B) (ErgoGrip LightGrey +3 more) by LM-Instruments Oy — Class IIa — MDD — listed in EUDAMED — 4 models — 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-06438311204215 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (1)
- EUDAMED 497ecd8c-7a81-4eea-b9b3-d18f0335f64f 61 fields · synced Aug 2, 2026