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Hygion

EUDAMED

Class I (EU MDR)

Ref HYG-UM400-170Model 2000+200ml，2000+350ml，2000+400ml，2000+500ml，2500+200ml，2500+350ml，2500+400ml，2500+500ml，2600+200ml，2600+350ml，2600+400ml，2600+500ml，3000+200ml，3000+350ml，3000+400ml，3000+500ml，3500+500mlRef 614

by Changshu Wilson Medical Devices Co., Ltd.

Identity

Trade Name
HYGION EUDAMED
Model / Reference
2000+200ml，2000+350ml，2000+400ml，2000+500ml，2500+200ml，2500+350ml，2500+400ml，2500+500ml，2600+200ml，2600+350ml，2600+400ml，2600+500ml，3000+200ml，3000+350ml，3000+400ml，3000+500ml，3500+500ml EUDAMED
HYG-UM400-170 EUDAMED
614 EUDAMED

Identifiers

Primary DI / UDI-DI
06972374226055 EUDAMED
06972374226147 EUDAMED
Basic UDI-DI
69723742202W4 EUDAMED
Direct Marketing DI
06972374226055 EUDAMED
06972374226147 EUDAMED
EMDN Code
A06030302 HOURLY DIURESIS MEASUREMENT SETS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Hygion by Changshu Wilson Medical Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Changshu Wilson Medical Devices Co., Ltd.
EUDAMED SRN
CN-MF-000032020
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 48fd13ad-97e3-4281-ae71-70d6f86f1507 61 fields · synced Oct 6, 2026
  • EUDAMED d4af5269-9c1b-4439-8713-f3ab41e8425a 61 fields · synced May 18, 2026