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upper body brace & splint

by Dongguan Hongfulin Intelligent Manufacturing Technology Co., LTD 65 variants

Ref HB12, NB06, BR18, EP12, SS09, HB15, SKPW3, BR10, HB13, NB05, SEP4, WB03, HB08, FB16, BR08, SS15, WB11, SS03, WB15, FB17, FB20, HB05, SS05, FB05, BR15, FB11, BR05, EP08, EP15, WB14, NB18, SS08, EP17, HB06, FB02, SS20, WB10, BR03, FB15, FB10, BR21, FB13, EP11, SS01, NB20, NB17, BR07, BR24, EP18, SS17, WB07Model HEAD BRACE ：HB01 HB02 HB03 HB04 HB05 HB06 HB07 HB08 HB09 HB10 HB11 HB12 HB13 HB14 HB15 HB16 HB17 HB18 HB19 HB20 NECK BRACE ：NB01 NB02 NB03 NB04 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 Number697862248ubbs001AN Basic UDI-DI Date14 May 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  • Withdrawn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
upper body brace & splint
Model / Reference
HEAD BRACE ：HB01 HB02 HB03 HB04 HB05 HB06 HB07 HB08 HB09 HB10 HB11 HB12 HB13 HB14 HB15 HB16 HB17 HB18 HB19 HB20 NECK BRACE ：NB01 NB02 NB03 NB04 etc, HB12, NB06, BR18, EP12, SS09, HB15, SKPW3, BR10, HB13, NB05, SEP4, WB03, HB08, FB16, BR08, SS15, WB11, SS03, WB15, FB17, FB20, HB05, SS05, FB05, BR15, FB11, BR05, EP08, EP15, WB14, NB18, SS08, EP17, HB06, FB02, SS20, WB10, BR03, FB15, FB10, BR21, FB13, EP11, SS01, NB20, NB17, BR07, BR24, EP18, SS17, WB07
Primary DI / UDI-DI
06978622480118, 06978622480255, 06978622481023, 06978622480736, 06978622480484, 06978622480149, 06978622481108, 06978622480941, 06978622480125, 06978622480248, 06978622480613, 06978622481146, 06978622480071, 06978622481474, 06978622480927, 06978622480545, 06978622481221, 06978622480422, 06978622481269, 06978622481481, 06978622481511, 06978622480040, 06978622480446, 06978622481368, 06978622480996, 06978622481429, 06978622480897, 06978622480699, 06978622480767, 06978622481252, 06978622480378, 06978622480477, 06978622480781, 06978622480057, 06978622481337, 06978622480590, 06978622481214, 06978622480873, 06978622481467, 06978622481412, 06978622481054, 06978622481443, 06978622480729, 06978622480408, 06978622480392, 06978622480361, 06978622480910, 06978622481085, 06978622480798, 06978622480569, 06978622481184
Basic UDI-DI
697862248ubbs001AN
EMDN Code
Y090612 Arm and elbow protections
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000045325
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