upper body brace & splint
by Dongguan Hongfulin Intelligent Manufacturing Technology Co., LTD China EUDAMED
Ref HB17Model 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
EMDN Y090612
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697862248ubbs001AN | Date14 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- 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, HB17
- Primary DI / UDI-DI
- 06978622480163
- Basic UDI-DI
- 697862248ubbs001AN
- EMDN Code
- Y090612 Arm and elbow protections
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045325
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dongguan Hongfulin Intelligent Manufacturing Technology Co., LTD
See all devices from Dongguan Hongfulin Intelligent Manufacturing Technology Co., LTD →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED e6f4281b-ecdb-40aa-ad40-3bc817455e0e