upper body brace & splint
by Dongguan Hongfulin Intelligent Manufacturing Technology Co., LTD 65 variants
Ref EP13Model 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
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697862248ubbs001AN 06978622480743 | Date14 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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, EP13
- Primary DI / UDI-DI
- 06978622480743
- 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