← Back to catalogue
Impression Tray Solid U1
EUDAMEDClass I (EU MDR)
Ref D-180-061Model Impression trays
Identity
- Trade Name
- IMPRESSION TRAY SOLID U1 EUDAMED
- Device Name
- IMPRESSION TRAY PERFORATED L1 EUDAMED
- Model / Reference
- Impression trays EUDAMEDD-180-061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104043176 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
Impression Tray 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mark One Surgical
- EUDAMED SRN
- PK-MF-000031202
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED a47c04b0-bb6d-4cdc-ae2c-7534970d6f53 61 fields · synced Jul 27, 2026