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Neteera 130H-Plus

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 210-00-103-00510(k) K231733

by Neteera Technologies Ltd.

Identity

Trade Name
Neteera 130H-Plus EUDAMED
Device Name
Neteera 130H-Plus EUDAMED
Model / Reference
210-00-103-00 EUDAMED

Identifiers

Primary DI / UDI-DI
07290117120002 EUDAMED
Basic UDI-DI
729011712130H-PlusXH EUDAMED
510(k) Number
K231733 FDA 510(k)
FDA Product Code
DRT FDA 510(k)
EMDN Code
Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

Neteera 130H-Plus by Neteera Technologies Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Neteera Technologies Ltd.
EUDAMED SRN
IL-MF-000043595
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED 97d3288e-96f2-4174-ba97-80e4a8c56679 61 fields · synced Jul 9, 2026
  • FDA 510(k) K231733 24 fields · synced May 18, 2026