Heka
by Allion BV h.o.d.n. van Heek Medical 67 variants
Ref WI0146-1
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 | Number8715886WindselsDF 08715886002544 | Date9 Feb 2024 | 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- Withdrawn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
- Bandages
- Model / Reference
- WI0146-1
- Primary DI / UDI-DI
- 08715886002544
- Basic UDI-DI
- 8715886WindselsDF
- Unit of Use DI
- 08715886002537
- EMDN Code
- M030402010101 Elastic support bandages, non-adhesive, extensible in one direction, high extensibility
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000003490
Other devices from Allion BV h.o.d.n. van Heek Medical
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