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Dental retractor

EUDAMED

Class I (EU MDR)

Ref CR12RModel CR01L,CR01S,CR02L,CR02M,CR02S,CR03,CR03L,CR03M,CR03S,CR04,CR04L,CR04S,CR05,CR05L,CR05S,CR06,CR07,CR09,CR09L,CR09M,CR09S,CR11L,CR11M,CR11S,CR12L,CR12M,CR12S,CR10,CR10M,CR10S,CR08,CR08L,CR08S,CR0802L,CR0802S,MP01,MP01L,MP01M,MP01S,MP02,MP02L,MP02M,MP02S

by Huanghua Promisee Dental Co.Ltd.

Identity

Trade Name
Dental retractor EUDAMED
Device Name
Dental Retractor EUDAMED
Model / Reference
CR01L,CR01S,CR02L,CR02M,CR02S,CR03,CR03L,CR03M,CR03S,CR04,CR04L,CR04S,CR05,CR05L,CR05S,CR06,CR07,CR09,CR09L,CR09M,CR09S,CR11L,CR11M,CR11S,CR12L,CR12M,CR12S,CR10,CR10M,CR10S,CR08,CR08L,CR08S,CR0802L,CR0802S,MP01,MP01L,MP01M,MP01S,MP02,MP02L,MP02M,MP02S EUDAMED
CR12R EUDAMED

Identifiers

Primary DI / UDI-DI
06954454011867 EUDAMED
Basic UDI-DI
69544540DERE001M3 EUDAMED
EMDN Code
Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Czechia 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

Dental retractor 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 bbbc78cf-706c-4707-ad6a-343638f17bcf 61 fields · synced Oct 7, 2026