Skip to content

Medical External Fixation Brace

by Tianjin Chenhai Medical instrument Co., Ltd.

Ref Head & Neck Medical External Fixation Brace-CH-N1001Model Head & Neck Medical External Fixation Brace: CH-N1001, CH-N1002, CH-N1003, CH-N1004, CH-N1005, CH-N1006, CH-N1007, CH-N1008, CH-N1009; Spine Medical External Fixation Brace: CH-S1001,CH-S1002, 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 Number697880652BRACE0017E Basic UDI-DI 06978806520005UDI-DIDate27 Jun 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  • Withdrawn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
Medical External Fixation Brace
Model / Reference
Head & Neck Medical External Fixation Brace: CH-N1001, CH-N1002, CH-N1003, CH-N1004, CH-N1005, CH-N1006, CH-N1007, CH-N1008, CH-N1009, Spine Medical External Fixation Brace: CH-S1001, CH-S1002, etc, Head & Neck Medical External Fixation Brace-CH-N1001
Primary DI / UDI-DI
06978806520005
Basic UDI-DI
697880652BRACE0017E
EMDN Code
Y0699 External prostheses and orthoses - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048386
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Chenhai Medical instrument 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