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Patient Monitor

by Shenzhen Witleaf Medical Electronics Co., Ltd 80 variants

Ref SPLF-MC, SATP-OX, SATP-SI, XH-60D, SATP-MC, XH-60B, XH-30B, W15, EK10C, EK12Q, E10K, E15C, W15C, F1A, EK10A, F12B, L10K, EK10, EK15C, L10B, L15K, EK12A, F18A, L12K, VS800B, L10P, W12, EK10J, EK15J, F15B, EK15, EK10K, L10J, EK10P, EK12C, L10Q, F18C, F15C, L15C, L15Q, EK15K, EK12B, L10C, EK15P, EK15A, F15A, EK15B, VS800

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 NumberB-06970005393176 Basic UDI-DI Date31 Oct 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06970005393176 Basic UDI-DI Date31 Oct 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
SPLF-MC, SATP-OX, SATP-SI, XH-60D, SATP-MC, XH-60B, XH-30B, W15, EK10C, EK12Q, E10K, E15C, W15C, F1A, EK10A, F12B, L10K, EK10, EK15C, L10B, L15K, EK12A, F18A, L12K, VS800B, L10P, W12, EK10J, EK15J, F15B, EK15, EK10K, L10J, EK10P, EK12C, L10Q, F18C, F15C, L15C, L15Q, EK15K, EK12B, L10C, EK15P, EK15A, F15A, EK15B, VS800
Primary DI / UDI-DI
06970005393176, 06970005393480, 06970005393466, 06970005393145, 06970005393459, 06970005393121, 06970005393428, 06970005395002, 06970005396900, 06970005396856, 06970005396450, 06970005396030, 06970005395033, 06970005390922, 06970005396887, 06970005390434, 06970005397754, 06970005396870, 06970005396740, 06970005397723, 06970005397358, 06970005396801, 06970005390021, 06970005397556, 06970005398027, 06970005397747, 06970005394005, 06970005396948, 06970005396788, 06970005390236, 06970005396719, 06970005396924, 06970005397778, 06970005396917, 06970005396825, 06970005397761, 06970005390045, 06970005390243, 06970005397334, 06970005397365, 06970005396764, 06970005396818, 06970005397730, 06970005396757, 06970005396726, 06970005390229, 06970005396733, 06970005398003
Basic UDI-DI
B-06970005393176, B-06970005393480, B-06970005393466, B-06970005393145, B-06970005393459, B-06970005393121, B-06970005393428, 697000539PMWTEL63S21ES, 697000539PMWX60S30S11Z8
Direct Marketing DI
06970005395002
06970005396900
06970005396856
06970005396450
06970005396030
06970005395033
06970005390922
06970005396887
06970005390434
06970005393121
06970005397754
06970005396870
06970005396740
06970005397723
06970005397358
06970005396801
06970005390021
06970005397556
06970005398027
06970005397747
06970005394005
06970005396948
06970005396788
06970005390236
06970005396719
06970005396924
06970005397778
06970005396917
06970005396825
06970005397761
06970005390045
06970005390243
06970005397334
06970005397365
06970005393428
06970005396764
06970005396818
06970005397730
06970005396757
06970005393145
06970005396726
06970005390229
06970005396733
06970005398003
EMDN Code
Z1203020202, Z1203020201
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000040494
Authorised representative
Zug Medical Systems FR-AR-000032031

Other devices from Shenzhen Witleaf Medical Electronics Co., Ltd.

See all devices from Shenzhen Witleaf Medical Electronics Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No