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Gutta Plugger Yellow 3/1 Silicon Handle
EUDAMEDClass I (EU MDR)
Ref D-114-744-BModel CARVER
Identity
- Trade Name
- GUTTA PLUGGER YELLOW 3/1 SILICON HANDLE EUDAMED
- Device Name
- INTERPROXIMAL CARVER HOLLENBACK , SOLID FIG.4 EUDAMED
- Model / Reference
- CARVER EUDAMEDD-114-744-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104041165 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
Gutta Plugger Yellow 3/1 Silicon Handle 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 6d4d0b3e-f592-40aa-814c-41d29b22a7d3 61 fields · synced Jul 16, 2026