Identity
- Trade Name
- Spatula Compactor EUDAMED
- Device Name
- Spatula Compactor EUDAMED
- Model / Reference
- 1642 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G54814420 EUDAMED
- Basic UDI-DI
- ++G548164249 EUDAMED
- EMDN Code
- L159013 DENTAL SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Spatula Compactor by Prilanta Surgical — 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 | ++G548164249 | Class I | Active |
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Manufacturer
- Manufacturer
- Prilanta Surgical
- EUDAMED SRN
- PK-MF-000038228
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED b5a169d0-9bdc-4e80-8c46-845f99662e90 61 fields · synced Aug 1, 2026