MED-TECH INC.

Certificate MDR 778677

Rev. R000Issued

Valid until: Jun 4, 2031

Certificate MDR 778677 is a valid Quality management system issued to MED-TECH INC. and registered in EUDAMED. Valid until June 4, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 778677
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 778677R000

Validity

Issued: Jun 5, 2026
Valid from: Jun 5, 2026
Valid until: Jun 4, 2031

Manufacturer

Manufacturer: MED-TECH INC.
Manufacturer SRN: JP-MF-000016597
Manufacturer country: Japan

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

Blood Purification Equipment
Class IIb

Documents

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