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Back brace

by Shijiazhuang RunYi Medical Device Technology Co., ltd 3 variants

Ref W009 L, W001(S), W001(XL)Model W001,W002,W003,W004,W005,W006,W007,W008,W009,W010,W011,W012,W013, W014,W015,W016,W017,W018,W019,W020,W021,W022,W023,W024,W025,W026, W027,W028,W029,W030,W031,W032,W033,W034,W035,W036,W037,W038,W039, W040,W041,W042,W043,W044,etc

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 Number697619156BB01JJ Basic UDI-DI Date26 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Back brace
Model / Reference
W001, W002, W003, W004, W005, W006, W007, W008, W009, W010, W011, W012, W013, W014, W015, W016, W017, W018, W019, W020, W021, W022, W023, W024, W025, W026, W027, W028, W029, W030, W031, W032, W033, W034, W035, W036, W037, W038, W039, W040, W041, W042, W043, W044, etc, W009 L, W001(S), W001(XL)
Primary DI / UDI-DI
06976191560231, 06976191560019, 06976191560040
Basic UDI-DI
697619156BB01JJ
EMDN Code
Y060306 Thoracolumbar orthoses
Device Class
Class I
EU market of registration
Austria
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000034467
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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