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Cervical Collar /Neck Brace/Philedelpha collar

by Irufa Industrial Group CO., LTD. 3 variants

Ref NK-SF-22Model Neck brace/Cervical Collar /Philedelphia Collar

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471996166NECKMA Basic UDI-DI 04719961661712UDI-DIDate21 Feb 2025RegisteredStatusActive

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  • Withdrawn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
Neck brace/Cervical Collar /Philedelphia Collar
Model / Reference
Neck brace/Cervical Collar /Philedelphia Collar, NK-SF-22
Primary DI / UDI-DI
04719961661712
Basic UDI-DI
471996166NECKMA
EMDN Code
Y060312 Cervical spine orthoses
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
TW-MF-000046083
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Other devices from Irufa Industrial Group CO., LTD.

See all devices from Irufa Industrial Group 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