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Dental high speed turbine handpiece

EUDAMED

Class IIa (EU MDR)

Ref Lotus 303PB-M4Model Lotus401-M4/Lotus401-B2/Lotus401P-M4/Lotus401P-B2/Lotus402-M4/Lotus402-B2/Lotus402P-M4/Lotus402P-B2/Lotus403-M4/Lotus403-B2/Lotus403P-M4/Lotus403P-B2/Lotus401PQ/Lotus401PBQ/Lotus401P45

by Being Foshan Medical Equipment Co., Ltd.

Identity

Trade Name
Dental high speed turbine handpiece EUDAMED
Device Name
Dental high speed turbine handpiece EUDAMED
Model / Reference
Lotus401-M4/Lotus401-B2/Lotus401P-M4/Lotus401P-B2/Lotus402-M4/Lotus402-B2/Lotus402P-M4/Lotus402P-B2/Lotus403-M4/Lotus403-B2/Lotus403P-M4/Lotus403P-B2/Lotus401PQ/Lotus401PBQ/Lotus401P45 EUDAMED
Lotus 303PB-M4 EUDAMED

Identifiers

Primary DI / UDI-DI
06941617210755 EUDAMED
Basic UDI-DI
69416172HSM3Q EUDAMED
Direct Marketing DI
06941617210755 EUDAMED
EMDN Code
Z12110102 DENTAL DRILLS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Bulgaria 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

Dental high speed turbine handpiece by Being Foshan Medical Equipment Co., Ltd. — Class IIa — 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
Being Foshan Medical Equipment Co., Ltd.
EUDAMED SRN
CN-MF-000028786
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 42211bfa-f07b-4653-9b06-7d6ca7bbc501 61 fields · synced Jun 17, 2026