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Gauze Balls with X-ray

EUDAMED

Class IIa (EU MDR)

Ref 013Model Gauze Balls with X-ray detectable, Gauze Sponges/Swabs with X-ray detectable

by Shaoxing Gangfeng Hospital Products Co., Ltd.

Identity

Trade Name
Gauze Balls with X-ray EUDAMED
Device Name
Gauze Sponges/Swabs/Balls with X-ray detectable EUDAMED
Model / Reference
Gauze Balls with X-ray detectable, Gauze Sponges/Swabs with X-ray detectable EUDAMED
013 EUDAMED

Identifiers

Primary DI / UDI-DI
06947872504738 EUDAMED
Basic UDI-DI
69478725IIa9V EUDAMED
EMDN Code
M0201020201 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Gauze Balls with X-ray by Shaoxing Gangfeng Hospital Products Co., Ltd. — Class IIa — 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

EUDAMED SRN
CN-MF-000008133
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 5d09b21d-0b49-4141-bb39-186213a0f7f1 61 fields · synced Oct 8, 2026