Identity
- Trade Name
- Dental Sinus Retractor EUDAMED
- Device Name
- Dental Sinus Retractor EUDAMED
- Model / Reference
- 1152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G54811520 EUDAMED
- Basic UDI-DI
- ++G54811523K EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, 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
Dental Sinus Retractor 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 | ++G54811523K | 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 d0a78dc9-fb4e-411a-9d01-982b14f7090c 61 fields · synced Jun 19, 2026