Low Temperature Steam-Formaldehyde Sterilizer

by Shinva Medical Instrument Co., Ltd. 5 variants

Ref FS-130Model FS-130，FS-M130，FS-K130，FS-M220，FS-L130

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697061496120012R3 Basic UDI-DI 06970614962985UDI-DI	Date16 Oct 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: FS-130，FS-M130，FS-K130，FS-M220，FS-L130, FS-130

Primary DI / UDI-DI: 06970614962985
Basic UDI-DI: 697061496120012R3
EMDN Code: Z12011303 Chemical sterilisation equipment

Device Class: Class IIa
EU market of registration: Romania

Manufacturer details

EUDAMED SRN: CN-MF-000009856
Authorised representative: MedNet EC-REP C IIb GmbH DE-AR-000011194

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Low Temperature Steam-Formaldehyde Sterilizer

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Class I
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Class A
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See all devices from Shinva Medical Instrument Co., Ltd. →

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No