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Neck Brace

by Shijiazhuang Mailaike Medical Devices Co., Ltd

Ref Philadelphia Cervical Collar:NS001Model Philadelphia Cervical Collar: NS001,NS002-1,NS002-2,NS003 Soft Cervical Collar: NS004,NS005,NS006,NS007,NS008,NS009,NS010,NS012,NS013,NS014,NS015 Rigid Cervical Collar： NS016,NS017,NS018,NS019，NS020, 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697839742NB001N5 Basic UDI-DI 06978397427189UDI-DIDate4 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Model / Reference
Philadelphia Cervical Collar: NS001, NS002-1, NS002-2, NS003 Soft Cervical Collar: NS004, NS005, NS006, NS007, NS008, NS009, NS010, NS012, NS013, NS014, NS015 Rigid Cervical Collar： NS016, NS017, NS018, NS019，NS020, etc., Philadelphia Cervical Collar:NS001
Primary DI / UDI-DI
06978397427189
Basic UDI-DI
697839742NB001N5
EMDN Code
Y060312 Cervical spine orthoses
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047242
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shijiazhuang Mailaike Medical Devices 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