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Vacuum Forming Sheet

by Zhengzhou Huaer Electro-optics Technology Co, Ltd. EUDAMED

Active European Union

Ref 06974041280681, 06974041280674Model HR-ZPS01,HR-ZPS02,HR-ZPS03,HR-ZPS04,HR-ZPS05,HR-ZPR01,HR-ZPR02,HR-ZPR03,HR-ZPR04,HR-ZPR05, HR-ZTS01,HR-ZTD01,HR-ZTT01,HR-ZTT02

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697404128HRVF01L9 Basic UDI-DIDate21 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Vacuum Forming Sheet
Model / Reference
HR-ZPS01, HR-ZPS02, HR-ZPS03, HR-ZPS04, HR-ZPS05,HR-ZPR01, HR-ZPR02, HR-ZPR03, HR-ZPR04, HR-ZPR05, 06974041280681, HR-ZTS01, HR-ZTD01, HR-ZTT01, HR-ZTT02, 06974041280674
Primary DI / UDI-DI
06974041280681, 06974041280674
Basic UDI-DI
697404128HRVF01L9, 697404128HZPR01PK
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003166
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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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