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Excellent Green Shield

by Xinle Huabao Medical Products Co., Ltd. 129 variants

Ref B(Non-sterile)-Ⅱ-MModel B(Non-sterile)

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 Number697480258PEGown002UY Basic UDI-DI Date29 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  • Withdrawn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
PE film PE Gowns
Model / Reference
B(Non-sterile), B(Non-sterile)-Ⅱ-M
Primary DI / UDI-DI
16974802581313, 06974802581316
Basic UDI-DI
697480258PEGown002UY
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008893
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xinle Huabao Medical Products Co., Ltd.

See all devices from Xinle Huabao Medical Products 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