219HKI01
by HORIZONTE Projects GmbH 2 variants
Ref 219HKI01V02
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 | Number42505276219-HKI-01NH 04250527628812 | Date16 Jun 2026 | 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- Withdrawn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
- 219HKI01
- Model / Reference
- 219HKI01V02
- Primary DI / UDI-DI
- 04250527628812
- Basic UDI-DI
- 42505276219-HKI-01NH
- EMDN Code
- M0303010201 Elastic fixing bandages, self-adhesive, extensible in one direction
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006580
Other devices from HORIZONTE Projects GmbH
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