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calf cover

by Shijiazhuang Runlei Labour Protection Supplies Co., Ltd

Ref RL-P6001Model RL-P6001;RL-P6002 ;RL-P6003;RL-P6004; RL-P6005;RL-P6006;RL-P6007;RL-P6008;RL-P6009; RL-P6010

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 Number697886443CC001KK Basic UDI-DI 06978864430315UDI-DIDate24 Sep 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  • Withdrawn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
calf cover
Model / Reference
RL-P6001, RL-P6002, RL-P6003, RL-P6004, RL-P6005, RL-P6006, RL-P6007, RL-P6008, RL-P6009, RL-P6010
Primary DI / UDI-DI
06978864430315
Basic UDI-DI
697886443CC001KK
EMDN Code
Y090618 Leg and knee protections (including socks for amputated legs)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048650
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shijiazhuang Runlei Labour Protection Supplies 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