DE-KA Titan
by DE-KA Titan Medical Germany e.K.
Ref 2011Model DE-KA Titan
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 | Number426255667DE-KA-SPDY 04262556670021 | Date13 Nov 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- Withdrawn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
- Model / Reference
- DE-KA Titan, 2011
- Primary DI / UDI-DI
- 04262556670021
- Basic UDI-DI
- 426255667DE-KA-SPDY
- EMDN Code
- N99 Nervous and medullary system devices - other
- Device Class
- Class I
- Medical Purpose
- The DE-KA Titan is a non-powered, passive analgesia device intended to reduce pain perception in patients by modulating pain signal transmission in the nervous system. The device is designed as a bracelet made of high-grade titanium, intended for external use in direct contact with the skin. It operates without power, sterility, or absorbent components and relies on patient-generated pain stimuli (changes in electrical potential) to activate its internal capacitor, which smoothens pain signal transmission. The device is intended for self-use by the patient and does not deliver pharmacological, immunological, or metabolic effects.
Manufacturer details
- EUDAMED SRN
- DE-PR-000050297
Properties
Other properties (1)
- Sterile: No