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Dry Field System

EUDAMED

Class I (EU MDR)

Ref /Model 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
Dry Field System 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
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06954454000915 EUDAMED
Basic UDI-DI
69544540DERE001M3 EUDAMED
EMDN Code
Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy 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

Dry Field System 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 0c6cd2a1-1f1a-469a-a47c-ccbcb9c304d9 61 fields · synced Jun 18, 2026