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Quickclean

by Hangzhou Singclean Medical Products Co., Ltd. 6 variants

Ref ORT-QC-10-2.0, ORT-QC-12-2.0, ORT-QC-20-2.0, ORT-QC-20-3.0, ORT-QC-10-2.5, MPH-QC-5.0, MPH-QC-0.5, MPH-QC-3.0, MPH-QC-1.0Model 10 mg/mL: 2.0 mL, 12 mg/mL: 2.0 mL, 20 mg/mL: 2.0 mL, 20 mg/mL: 3.0 mL, 10 mg/mL: 2.5 mL, 0.5g/Piece, 1.0g/Piece, 2.0g/Piece, 3.0g/Piece, 5.0g/Piece

Active European Union

CE MDR CE MDD

Valid until

2 Dec 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DNV Product Assurance AS

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-06936020110051 Basic UDI-DI Date24 Mar 2025RegisteredStatusActive
European UnionCE/MDD NumberB-06936020110051 Basic UDI-DI Date24 Mar 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • C544578 Active

    Technical documentation EU MDR

    Certifier
    DNV Product Assurance AS 2460
    Issued
    3 Dec 2024
    Expires
    2 Dec 2029
  • C637543 Active

    Quality management system EU MDR

    Certifier
    DNV Product Assurance AS 2460
    Issued
    3 Dec 2024
    Expires
    2 Dec 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Medical Sodium Hyaluronate Gel for Bone Joint
MPH Absorbable Hemostatic Particles
Model / Reference
10 mg/mL: 2.0 mL, ORT-QC-10-2.0, 12 mg/mL: 2.0 mL, ORT-QC-12-2.0, 20 mg/mL: 2.0 mL, ORT-QC-20-2.0, 20 mg/mL: 3.0 mL, ORT-QC-20-3.0, 10 mg/mL: 2.5 mL, ORT-QC-10-2.5, 0.5g/Piece, 1.0g/Piece, 2.0g/Piece, 3.0g/Piece, 5.0g/Piece, MPH-QC-5.0, MPH-QC-0.5, MPH-QC-3.0, MPH-QC-1.0
Primary DI / UDI-DI
06936020110051, 06936020110068, 06936020110099, 06936020109949, 06936020110075, 06936020111881, 06936020106443, 06936020106405, 06936020106436, 06936020106412
Basic UDI-DI
B-06936020110051, B-06936020110068, B-06936020110099, B-06936020109949, B-06936020110075, B-06936020111881, 69360201248S
EMDN Code
P900402, M040599
Device Class
Class III
EU market of registration
Spain
Czechia
Austria

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

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