Electronic Nasopharyngeal Endoscope

by Shenzhen Insighters Medical Technology Co., Ltd. 29 variants

Ref iS-ENF32Model iS-ENF22, iS-ENC32, iS-ENC42, iS-ENF32, iS-ENF42

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697083172ENZK Basic UDI-DI 06977800302013UDI-DI	Date12 Mar 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: iS-ENF22, iS-ENC32, iS-ENC42, iS-ENF32, iS-ENF42

Primary DI / UDI-DI: 06977800302013
Basic UDI-DI: 697083172ENZK
Direct Marketing DI: 06977800302013
EMDN Code: R010101 Nasopharyngeal tubes

Device Class: Class I
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000032018
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Insighters Medical Technology Co., Ltd.

Electronic Nasopharyngeal Endoscope

Class I
Reusable Laryngoscope Blade

Class I
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Class I
Video Laryngoscope Accessories

Class I
Video Processor

Class I
Electronic Nasopharyngeal Endoscope

Class I

See all devices from Shenzhen Insighters Medical Technology Co., Ltd. →

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No