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Neo Pe Gloves

by Zhangjiagang Wenhao Industrial Co., Ltd

Ref 286541Model HDPE GLOVES, LDPE GLOVES, CPE GLOVES, TPE GLOVES

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 Number697449026gloveGE Basic UDI-DI 06974490260418UDI-DIDate30 Mar 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  • Withdrawn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
Pe Gloves
Model / Reference
HDPE GLOVES, LDPE GLOVES, CPE GLOVES, TPE GLOVES, 286541
Primary DI / UDI-DI
06974490260418
Basic UDI-DI
697449026gloveGE
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000008448
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhangjiagang Wenhao Industrial 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