Negative Pressure Wound Therapy Instrument

by SAC(Xiamen) Medical Technology Co., Ltd.

Ref 6001003000Model SAC-NPS-3000

Active European Union

CE MDR CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	Number69586550YQ01001UV Basic UDI-DI 06958655002068UDI-DI	Date20 May 2026Registered	StatusActive
European Union	CE/MDR	Number69586550YQ01001UV Basic UDI-DI 06958655002068UDI-DI	Date20 May 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Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Model / Reference: 6001003000, SAC-NPS-3000

Primary DI / UDI-DI: 06958655002068
Basic UDI-DI: 69586550YQ01001UV, B-06958655002068
EMDN Code: Z12019003 Wound treatment equipment

Device Class: Class IIa
EU market of registration: Hungary

Manufacturer details

EUDAMED SRN: CN-MF-000023943
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from SAC(Xiamen) Medical Technology Co., Ltd.

Single Use Sterile Pulse Flushing System for Wound Care

Class IIa

Properties

Reusable

Other properties (12)

Sterile: No
Implantable: 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