Identity
- Trade Name
- P.K Thomas CARVER EUDAMED
- Device Name
- P.K Thomas CARVER EUDAMED
- Model / Reference
- 1641 EUDAMED1640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G54816410 EUDAMEDG54816400 EUDAMED
- Basic UDI-DI
- ++G548164147 EUDAMED++G548164045 EUDAMED
- EMDN Code
- L159017 DENTAL RESTORATION CARVERS, 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
P.K Thomas CARVER 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 | ++G548164147 | 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 (2)
- EUDAMED 947b11ff-152d-4a0e-ad93-eb9657ad4509 61 fields · synced Aug 2, 2026
- EUDAMED df8d30b9-fd38-4ccd-9406-05263e56d269 61 fields · synced May 17, 2026