Identity
- Trade Name
- P.K THOMAS , SOLID FIG. 5 EUDAMED
- Device Name
- INTERPROXIMAL CARVER HOLLENBACK , SOLID FIG.4 EUDAMED
- Model / Reference
- CARVER EUDAMEDD-110-695 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104041134 EUDAMED
- Basic UDI-DI
- 896110404CARVER/CLASSIM6 EUDAMED
- EMDN Code
- L159017 DENTAL RESTORATION CARVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
P.k Thomas , Solid Fig. 5 by Mark One 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 | 896110404CARVER/CLASSIM6 | Class I | Active |
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Manufacturer
- Manufacturer
- Mark One Surgical
- EUDAMED SRN
- PK-MF-000031202
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED b72361c3-81f4-4d96-b0b2-28ad2fe93160 61 fields · synced Jun 18, 2026