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Mpression Tray Regular Solid U1
EUDAMEDClass I (EU MDR)
Ref D-181-089Model Impression trays
Identity
- Trade Name
- MPRESSION TRAY REGULAR SOLID U1 EUDAMED
- Device Name
- IMPRESSION TRAY PERFORATED L1 EUDAMED
- Model / Reference
- Impression trays EUDAMEDD-181-089 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104043381 EUDAMED
- Basic UDI-DI
- 896110404IMP/TAYCLASSIUT EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY 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
Mpression Tray Regular Solid U1 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 | 896110404IMP/TAYCLASSIUT | 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 4e69c27a-7fcb-4135-9c64-15ad498c525a 61 fields · synced Jul 9, 2026