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Patient Positioning Devices and Supports

by Lesotek (Guangzhou) Co., Ltd.

Ref PAD01Model PAD01,PAD02,PAD03,PAD04,PAD05,PAD06,TLS01,TLS02,TLS03,TLS04,TLS05,TLS06,PPS01,PPS02,PPS03,PPS04,PPS05,PPS06,AP01,AP02,AP03,AP04,AP05,AP06,AP07,HP01,HP02,HP03,HP04,HP05, etc

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 Number697874197PPDAS01CC Basic UDI-DI 06978741970002UDI-DIDate30 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Patient Positioning Devices and Supports
Model / Reference
PAD01, PAD02, PAD03, PAD04, PAD05, PAD06, TLS01, TLS02, TLS03, TLS04, TLS05, TLS06, PPS01, PPS02, PPS03, PPS04, PPS05, PPS06, AP01, AP02, AP03, AP04, AP05, AP06, AP07, HP01, HP02, HP03, HP04, HP05, etc
Primary DI / UDI-DI
06978741970002
Basic UDI-DI
697874197PPDAS01CC
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048338
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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