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ROMAN 4 Pearl Dot SMOOTH
EUDAMEDClass I (EU MDR)
Ref 27554Model FORCEPS, ORTHODONTIC
Identity
- Trade Name
- ROMAN 4 Pearl Dot SMOOTH EUDAMED
- Device Name
- Orthodontic Pliers EUDAMED
- Model / Reference
- FORCEPS, ORTHODONTIC EUDAMED27554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04963931275540 EUDAMED
- Basic UDI-DI
- 4963931YDM00001WE EUDAMED
- EMDN Code
- L150702 ORTHODONTIC PLIERS, 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
ROMAN 4 Pearl Dot SMOOTH by Ydm Corporation — 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 | 4963931YDM00001WE | Class I | Active |
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Manufacturer
- Manufacturer
- Ydm Corporation
- EUDAMED SRN
- JP-MF-000011653
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED b5f7dbea-8298-488e-bc64-30f2cf1d995a 61 fields · synced Jul 12, 2026