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Medical Dressing

by Shandong Shingna Medical Products Co., Ltd.

Ref MDN 1204, 1204Model D4545, D/Surgical Films

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-16975670551644 Basic UDI-DI 16975670551644UDI-DIDate9 Jun 2025RegisteredStatusActive
European UnionCE/MDD NumberB-16975670551644 Basic UDI-DI 16975670551644UDI-DIDate9 Jun 2025RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
Medical Dressing
Medical Dressings--Surgical Films
Device Name
Medical Dressing （Surgical Film）
Medical Dressings
Model / Reference
D4545, MDN 1204, D/Surgical Films, 1204
Primary DI / UDI-DI
16975670551644
Basic UDI-DI
B-16975670551644, 697567055ddressingsBF
Direct Marketing DI
16975670551644
EMDN Code
M04010202 Polyurethane fixing dressings
Device Class
Class I
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000001937
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shandong Shingna Medical Products Co., Ltd.

See all devices from Shandong Shingna Medical Products 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