Identity
- Trade Name
- Sickle Scaler EUDAMED
- Device Name
- Sickle Scaler EUDAMED
- Model / Reference
- MD3401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G520MD34010 EUDAMED
- Basic UDI-DI
- ++G520MD3401KP EUDAMED
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Sickle Scaler by Medspo — Class I — 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 | ++G520MD3401KP | Class I | Active |
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Manufacturer
- Manufacturer
- Medspo
- EUDAMED SRN
- PK-MF-000037594
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED cef08672-0e5b-4b07-9e5a-9a6d5e9ba647 61 fields · synced Jul 9, 2026