BANDANA kurz
by Werkmeister GmbH + Co. KG 3 variants
Ref 15KZ, 14KZ, 15KZZW
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 | Number4048486231101YC | Date1 Sep 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- Withdrawn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
- Trade Name
- BANDANA kurzBANDANA kurz mit Zwickel
- Device Name
- Rumpfstützorthese
- Model / Reference
- 15KZ, 14KZ, 15KZZW
- Primary DI / UDI-DI
- 04048486073879, 04048486073862, 04048486073626, 04048486074036, 04048486074005, 04048486073893, 04048486074012, 04048486073947, 04048486073848, 04048486073664, 04048486073930, 04048486073633, 04048486073923, 04048486073992, 04048486073824, 04048486073657
- Basic UDI-DI
- 4048486231101YC
- Direct Marketing DI
- 04048486073879040484860738620404848607362604048486074036040484860740050404848607389304048486074012040484860739470404848607384804048486073664040484860739300404848607363304048486073923040484860739920404848607382404048486073657
- EMDN Code
- Y060499 Abdominal orthoses - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005120
Other devices from Werkmeister GmbH + Co. KG
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