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Surgical Positioning Pad

by Hi-Life Technology (Hebei) Co., Ltd 3 variants

Ref SPPA812Model HL-A8120series、HL-A8121series、HL-A8122series、HL-A8123series、HL-A8124series、HL-A8125series、HL-A8126series、HL-A8127series

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697546136SPPA8123V Basic UDI-DI 06975461368126UDI-DIDate8 Apr 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  • Withdrawn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

Model / Reference
HL-A8120series、HL-A8121series、HL-A8122series、HL-A8123series、HL-A8124series、HL-A8125series、HL-A8126series、HL-A8127series, SPPA812
Primary DI / UDI-DI
06975461368126
Basic UDI-DI
697546136SPPA8123V
Direct Marketing DI
06975461368126
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000023965
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hi-Life Technology (Hebei) Co., Ltd

See all devices from Hi-Life Technology (Hebei) 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