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Surgiclean®

by Hangzhou Singclean Medical Products Co., Ltd. 21 variants

Ref ORC-SG-30×30Model 30cm*30cm/pc, 2cm*3cm/pc，3cm*5cm /pc，5cm*8cm /pc，7cm*8cm/pc，10cm*15cm/pc ，10cm*20cm/pc，5cm*5cm /pc，5cm*7.5cm/pc，5cm*10cm/pc，5cm*25cm/pc 5cm*30cm /pc，5cm*35cm/pc 10cm*10cm/pc，30cm*30cm/pc 30cm*50cm/pc，22.5cm*22.5cm/pc

Active European Union

CE MDR CE MDD

Valid until

14 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2026/0024 Date15 May 2026IssuedStatusActive expires 14 May 2031
European UnionCE/MDD NumberB-06936020109789 Basic UDI-DI 06936020109789UDI-DIDate28 Oct 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0024 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    15 May 2026
    Expires
    14 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Absorbable Gauze of Oxidized Regenerated Cellulose
Model / Reference
30cm*30cm/pc, ORC-SG-30×30, 2cm*3cm/pc，3cm*5cm /pc，5cm*8cm /pc，7cm*8cm/pc，10cm*15cm/pc ，10cm*20cm/pc，5cm*5cm /pc，5cm*7.5cm/pc，5cm*10cm/pc，5cm*25cm/pc 5cm*30cm /pc，5cm*35cm/pc 10cm*10cm/pc，30cm*30cm/pc 30cm*50cm/pc，22.5cm*22.5cm/pc
Primary DI / UDI-DI
06936020109789
Basic UDI-DI
B-06936020109789, 69360201028G
EMDN Code
M040501 Polysaccharide haemostatic dressings
Device Class
Class III
EU market of registration
Italy
France

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
Hangzhou Singclean Medical Products Filial Sweden SE-AR-000047013

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties

  • Sterile
  • Implantable YesEUDAMEDNoEUDAMED

Other properties (11)

  • 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