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Polycare France

by Wuhan Zonsen Medical Products Co., Ltd 5 variants

Ref PK-2

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 Number697199986ZDC4B Basic UDI-DI Date29 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  • Withdrawn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

Device Name
Doctor cap
Shoe cover
Examination underpants
Patient gown
Model / Reference
PK-2
Primary DI / UDI-DI
06976128166482, 06976128167557, 06976128165713, 06976128166314
Basic UDI-DI
697199986ZDC4B, 697199986ZSC5Q, 697612816ZEUVR, 697199986ZPG5P
EMDN Code
T0207, T0208, T0299, T0205
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008034
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Wuhan Zonsen Medical Products Co., Ltd

See all devices from Wuhan Zonsen 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