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Friendship Medical

by Xi'an Friendship Medical Electronics Co., Ltd. 81 variants

Ref 5042Model DECL101500-SC, DECL

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, 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 NumberB-16955739050424 Basic UDI-DI 16955739050424UDI-DIDate24 Feb 2022RegisteredStatusActive
European UnionCE/MDD NumberB-16955739050424 Basic UDI-DI 16955739050424UDI-DIDate24 Feb 2022RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Medical EEG Ag/AgCl Cup Electrodes
Model / Reference
DECL101500-SC, 5042, DECL
Primary DI / UDI-DI
16955739050424
Basic UDI-DI
B-16955739050424, 695573904008LW
Unit of Use DI
06955739050427
EMDN Code
Z121002 Nervous system monitoring systems
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000004202
Authorised representative
Friendship Europe ApS DK-AR-000001593

Other devices from Xi'an Friendship Medical Electronics Co., Ltd.

See all devices from Xi'an Friendship Medical Electronics 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