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Compression Cuff

by Shenzhen Comen Medical Instruments Co., LTD. 27 variants

Ref FM-02-S, FO-01-P, HO-01-S, HO-01-N, FM-05-L, HO-03-F, HM-02, HM-01-P, FO-03, FM-02, FO-01-N, FM-01-S, FO-03-F, FM-01-P, HM-01, HM-03, FO-01-S, HO-01-S-F, FO-01, FM-01-L, FO-01-L, FO-01-F, FM-05, HO-01-L, HO-01-P-F, FO-02-P, FO-01-S-FModel FM-01

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69454290CC001GM Basic UDI-DI Date23 Nov 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
FM-01, FM-02-S, FO-01-P, HO-01-S, HO-01-N, FM-05-L, HO-03-F, HM-02, HM-01-P, FO-03, FM-02, FO-01-N, FM-01-S, FO-03-F, FM-01-P, HM-01, HM-03, FO-01-S, HO-01-S-F, FO-01, FM-01-L, FO-01-L, FO-01-F, FM-05, HO-01-L, HO-01-P-F, FO-02-P, FO-01-S-F
Primary DI / UDI-DI
06945429080155, 06945429080292, 06945429080346, 06945429080339, 06945429080254, 06945429080605, 06945429080209, 06945429080124, 06945429080438, 06945429080063, 06945429080148, 06945429080278, 06945429080070, 06945429080445, 06945429080087, 06945429080100, 06945429080216, 06945429080285, 06945429080537, 06945429080261, 06945429080094, 06945429080308, 06945429080315, 06945429080223, 06945429080360, 06945429080544, 06945429080407, 06945429080490
Basic UDI-DI
69454290CC001GM
Direct Marketing DI
06945429080155
06945429080292
06945429080346
06945429080339
06945429080254
06945429080605
06945429080209
06945429080124
06945429080438
06945429080063
06945429080148
06945429080278
06945429080070
06945429080445
06945429080087
06945429080100
06945429080216
06945429080285
06945429080537
06945429080261
06945429080094
06945429080308
06945429080315
06945429080223
06945429080360
06945429080544
06945429080407
06945429080490
EMDN Code
V0899 Medical support equipment - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000002236
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Comen Medical Instruments Co., LTD.

See all devices from Shenzhen Comen Medical Instruments 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