Central Monitoring System

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref TRUSCOPE CNS G2Model BioVision

by Guangdong Biolight Meditech Co., Ltd

Identity

Trade Name: Central Monitoring System EUDAMED
Device Name: Central Monitoring System EUDAMED
Model / Reference: BioVision EUDAMED
TRUSCOPE CNS G2 EUDAMED

Identifiers

Primary DI / UDI-DI: 06932562300943 EUDAMED
06932562300257 EUDAMED
Basic UDI-DI: 693256231001442 EUDAMED
EMDN Code: Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Special Device Type: Software EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Central Monitoring System by Guangdong Biolight Meditech Co., Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K153580	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K170514	Class IIb	Active
EUDAMED	European Union	CE/MDR	693256231001442	Class IIb	Active

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Manufacturer

Manufacturer: Guangdong Biolight Meditech Co., Ltd
EUDAMED SRN: CN-MF-000006333
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

EUDAMED 89a60d77-1e34-481b-acdc-3d61b639228f 61 fields · synced Aug 4, 2026
EUDAMED 74b5fac8-e50f-4542-bf7a-34a0f858f86d 61 fields · synced May 19, 2026
FDA 510(k) K153580 1 fields · synced May 18, 2026