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Impression Tray Solid L2

EUDAMED

Class I (EU MDR)

Ref D-180-056Model Impression trays

by Mark One Surgical

Identity

Trade Name
IMPRESSION TRAY SOLID L2 EUDAMED
Device Name
IMPRESSION TRAY PERFORATED L1 EUDAMED
Model / Reference
Impression trays EUDAMED
D-180-056 EUDAMED

Identifiers

Primary DI / UDI-DI
08961104043138 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

Category: Dental implant suprastructure, temporary, preformed, single-use

Impression Tray Solid L2 by Mark One Surgical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, temporary, preformed, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 f74b0eba-83a3-4700-8dc3-c068c26896fb 61 fields · synced Jul 9, 2026