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Impression Tray

EUDAMED

Class I (EU MDR)

Ref /Model IT01,IT0101,IT0102,IT0103,IT0104,IT0105,IT0106,IT0107,IT0108,IT0109,IT0110,IT02,IT0201,IT0202,IT0203,IT0204,IT0205,IT0206,IT0207,IT0208,IT0209,IT0210,IT05,IT07,BT,BT01,BT02,BT03,BT04,BT05,IT08,IT06,TB01,TB01L,TB01M,TB01S,BP01,BP02,BP03,BP04, BP04B

by Huanghua Promisee Dental Co.Ltd.

Identity

Trade Name
Impression Tray EUDAMED
Device Name
Impression Tray EUDAMED
Model / Reference
IT01,IT0101,IT0102,IT0103,IT0104,IT0105,IT0106,IT0107,IT0108,IT0109,IT0110,IT02,IT0201,IT0202,IT0203,IT0204,IT0205,IT0206,IT0207,IT0208,IT0209,IT0210,IT05,IT07,BT,BT01,BT02,BT03,BT04,BT05,IT08,IT06,TB01,TB01L,TB01M,TB01S,BP01,BP02,BP03,BP04, BP04B EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06954454005002 EUDAMED
Basic UDI-DI
69544540IMTR001WH EUDAMED
EMDN Code
Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

Yes

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 by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Huanghua Promisee Dental Co.Ltd.
EUDAMED SRN
CN-MF-000014766
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 5ca8a7ae-7219-4e18-b8b2-04a6cdbfa4a2 61 fields · synced Jun 18, 2026