BackieBelt
by MAR´CO, s.r.o. EUDAMED
Active
Ref REF-BB001-XLModel BB001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08588008909BackieBeltU3 | Date30 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- BB001, REF-BB001-XL
- Primary DI / UDI-DI
- 08588008909072
- Basic UDI-DI
- 08588008909BackieBeltU3
- EMDN Code
- Y060308 Lumbosacral spine orthoses
- Device Class
- Class I
- Market of Registration
- Slovakia
Manufacturer details
- EUDAMED SRN
- SK-MF-000053306
Other devices from MAR´CO, s.r.o.
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