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Organization name
UDI-DI code
Reference / catalog number

KFH.PERM.PEXA — Class IIa MDR by KfH Kuratorium für…

MD Atlas
KfH Kuratorium für Dialyse und Nierentransplantation e.V.

EUDAMED last updated this device on Apr 18, 2024

KFH.PERM.PEXA

PP12298KFH.PERM62

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
UDI-DI code: 1312298KFH.PERM.PEXA061
Reference / catalog number: KFH.PERM.PEXA

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Manufacturer information

Organization name: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
SRN: DE-MF-000018864
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 20, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: 1312298KFH.PERM.PEXA061
Basic UDI-DI: PP12298KFH.PERM62
Reference / catalog number: KFH.PERM.PEXA
Issuing entity: IFA

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Das KfH-Permeatringleitungssystem ist als Verbindungselement zwischen Wasseraufbereitungsanlage (RO-Anlage) und Hämodialysegerät zur Durchleitung von Dialysewasser (Permeat) in Dialyseeinrichtungen bestimmt.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12099007DIALYSIS WATER TREATMENT SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

KFH.KONZ.LLDPEPP12298KFH.KONZ91On the market KFH.PERM.PVDFPP12298KFH.PERM62On the market

Certificates

Certificate health across this manufacturer's portfolio.

G10 050705 0270Issued
Quality management systemNotified body: 0123Expiry: Sep 12, 2029