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Insufflator(with Insufflation Tube and Gas Filter)

EUDAMED

Class IIb (EU MDR)

Ref 4050039

by Guangdong OptoMedic Technologies, Inc.

Identity

Trade Name
Insufflator(with Insufflation Tube and Gas Filter) EUDAMED
Device Name
Insufflator(with Insufflation Tube and Gas Filter) EUDAMED
Model / Reference
4050039 EUDAMED

Identifiers

Primary DI / UDI-DI
06973031299351 EUDAMED
Basic UDI-DI
697303129WS01P01KL EUDAMED
EMDN Code
Z12029008 GAS INFLATORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Medical Purpose
The Insufflator (with Insufflation Tube and Gas Filter) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Insufflator(with Insufflation Tube and Gas Filter) by Guangdong Optomedic Technologies, Inc. — Class IIb — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Guangdong OptoMedic Technologies, Inc.
EUDAMED SRN
CN-PR-000043365

Sources (1)

  • EUDAMED d9d13395-493f-4621-bc00-e214e0694282 61 fields · synced Jun 18, 2026