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Surgiclean®

by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED

Ref ORC-SG-5×25Model 5cm*25cm/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 EMDN M040501

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2026/0024 Date15 May 2026IssuedStatusActive expires 14 May 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU MDR

    Notified body
    Notified body 2292
    Issued
    15 May 2026
    Expires
    14 May 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Absorbable Gauze of Oxidized Regenerated Cellulose
Model / Reference
5cm*25cm/pc, ORC-SG-5×25, 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
06936020109741
Basic UDI-DI
B-06936020109741, 69360201028G
EMDN Code
M040501 Polysaccharide haemostatic dressings
Device Class
Class III
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 41d00105-7e01-486e-a4ef-06045ff1d9c2 61 fields · synced 22 Oct 2026
  • EUDAMED 06936020109741|69360201028G 61 fields · synced 10 Oct 2026