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Dental Wedge

EUDAMED

Class I (EU MDR)

Ref /Model PW01,PW01L,PW01M,PW01S,PW01SS,PW02,PW02L,PW02M,PW02S,PW02SS,PW03,PW04,PW04L,PW04M,PW04S,PW05,PW05L,PW05M,PW05S,PW06,PW06L,PW06S,PW07,PW07L,PW07M,PW07S,WG01,WG01L,WG01M,WG01S,SC0301,RD09Ref PW02M

by Huanghua Promisee Dental Co.Ltd.

Identity

Trade Name
Dental Wedge EUDAMED
Device Name
Dental Wedge EUDAMED
Model / Reference
PW01,PW01L,PW01M,PW01S,PW01SS,PW02,PW02L,PW02M,PW02S,PW02SS,PW03,PW04,PW04L,PW04M,PW04S,PW05,PW05L,PW05M,PW05S,PW06,PW06L,PW06S,PW07,PW07L,PW07M,PW07S,WG01,WG01L,WG01M,WG01S,SC0301,RD09 EUDAMED
/ EUDAMED
PW02M EUDAMED

Identifiers

Primary DI / UDI-DI
06954454001806 EUDAMED
Basic UDI-DI
69544540DEWE001NS EUDAMED
EMDN Code
Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Finland EUDAMED
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

Yes

EUDAMEDEUDAMED

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 Wedge 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 (2)

  • EUDAMED 2db4224d-6595-4a46-a839-dcaefa192ef0 61 fields · synced Oct 10, 2026
  • EUDAMED cb47deef-bc11-46a0-8a71-b70d56ee907c 61 fields · synced Oct 10, 2026