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Laryngeal Mask Airway

EUDAMED

Class IIa (EU MDR)

Ref LM1004S12Model Silicone Laryngeal Mask Airway

by Ningbo Luke Medical Devices Co., LTD

Identity

Device Name
Laryngeal Mask Airway EUDAMED
Model / Reference
Silicone Laryngeal Mask Airway EUDAMED
LM1004S12 EUDAMED

Identifiers

Primary DI / UDI-DI
06970240896197 EUDAMED
Basic UDI-DI
697024089LMAQ8 EUDAMED
Direct Marketing DI
06970240896197 EUDAMED
EMDN Code
R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

Yes

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

Category: Laryngeal mask airway, single-use

Laryngeal Mask Airway by Ningbo Luke Medical Devices Co., LTD — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Laryngeal mask airway, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000011732
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED f702a752-8f23-4823-b81e-4a69c12ca571 61 fields · synced Jun 19, 2026