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PE-38 tip
EUDAMEDClass IIa (EU MDR)
Ref 100138Model Tip for an Ultrasonic scaler
Identity
- Trade Name
- PE-38 tip EUDAMED
- Model / Reference
- Tip for an Ultrasonic scaler EUDAMED100138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311200118 EUDAMED
- Basic UDI-DI
- B-06438311200118 EUDAMED
- EMDN Code
- L15900899 DENTAL EQUIPMENT TIPS NOT INCLUDED IN OTHER CLASSES, REUSABLE - OTHER 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
PE-38 tip by LM-Instruments Oy — 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-06438311200118 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (1)
- EUDAMED 0f4c772e-5714-4661-a937-33ec4f0c6205 61 fields · synced Jun 17, 2026