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Calibration Standard Solution

by Shenzhen Cornley Bio-Medical Co., Ltd. 4 variants

Ref 10.40.000065, /, 10.40.000111Model M-EM1, TS I 、TS II, M-E01,M-E02, ES I、ES II

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697287382M-EM1L7 Basic UDI-DI Date23 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
M-EM1, 10.40.000065, TS I 、TS II, /, M-E01, M-E02, 10.40.000111, ES I、ES II
Primary DI / UDI-DI
06972873821898, 06972873820198, 06972873820204, 06972873821911, 06972873820181
Basic UDI-DI
697287382M-EM1L7, 697287382TS74, 697287382M-E01M-E02BN, 697287382ES5P
Direct Marketing DI
06972873821898
06972873820198
06972873820204
06972873821911
06972873820181
EMDN Code
W0101050301, W0101050399
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000017322
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Cornley Bio-Medical Co., Ltd.

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No