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Disposable Dry Seal Chest Drainage Systems

by Ningbo Xinwell Medical Technology Co., Ltd 3 variants

Ref AFG31-1 100003748Model AFG31-1

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697194491AFG31-1HG Basic UDI-DI 06971944913159UDI-DIDate9 Feb 2026RegisteredStatusActive

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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
AFG31-1, AFG31-1 100003748
Primary DI / UDI-DI
06971944913159
Basic UDI-DI
697194491AFG31-1HG
EMDN Code
A06010199 Vacuum and gravity drainage systems - other
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000001084
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Xinwell Medical Technology Co., Ltd.

See all devices from Ningbo Xinwell Medical Technology Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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