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Singjoint

by Hangzhou Singclean Medical Products Co., Ltd. 3 variants

Ref ORT-SJ-10-1.0, ORT-SJ-20-3.0, ORT-SJ-20-2.0, ORT-SJ-10-2.5, ORT-SJ-12-1.0, ORT-SJ-10-2.0Model 10mg/mL：1ml, 20mg/mL: 3mL, 20mg/mL: 2mL, 10mg/mL: 2.5mL, 12mg/mL: 1mL, 10mg/mL: 2mL

Active European Union

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/MDD NumberB-06936020100083 Basic UDI-DI Date11 Mar 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Medical Sodium Hyaluronate Gel for Bone Joint
Model / Reference
10mg/mL：1ml, ORT-SJ-10-1.0, 20mg/mL: 3mL, ORT-SJ-20-3.0, 20mg/mL: 2mL, ORT-SJ-20-2.0, 10mg/mL: 2.5mL, ORT-SJ-10-2.5, 12mg/mL: 1mL, ORT-SJ-12-1.0, 10mg/mL: 2mL, ORT-SJ-10-2.0
Primary DI / UDI-DI
06936020100083, 06936020100090, 06936020109895, 06936020100052, 06936020100403, 06936020100045
Basic UDI-DI
B-06936020100083, B-06936020100090, B-06936020109895, B-06936020100052, B-06936020100403, B-06936020100045
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Spain

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 (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No