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Positioning Pads

by Auckland Medical Polymer (Tianjin) Co., Ltd. 44 variants

Ref 1104Model 1100 group、2100 group、3100 group、4100 group、 5100 group、6100 group、7100 group、8000 group、 8100 group、9100 group

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69534970SSD102V5 Basic UDI-DI 06953497005284UDI-DIDate16 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Positioning Pads
Model / Reference
1100 group、2100 group、3100 group、4100 group、 5100 group、6100 group、7100 group、8000 group、 8100 group、9100 group, 1104
Primary DI / UDI-DI
06953497005284
Basic UDI-DI
69534970SSD102V5
Direct Marketing DI
06953497005284
EMDN Code
V080302 Patient positioning medical cushions
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000033571
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Auckland Medical Polymer(Tianjin) Co., Ltd.

See all devices from Auckland Medical Polymer(Tianjin) Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • 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