Alfa Handledsortos Höger Small
by Promedics Orthopaedics Limited 4 variants
Ref 3110-23
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 | Number50554741B17H 05050996015767 | Date6 Aug 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- Withdrawn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
EU market availability
Made available in 31 countries, as listed in EUDAMED:
- Austria since 26 Jul 2022
- Belgium since 26 Jul 2022
- Bulgaria since 26 Jul 2022
- Croatia since 26 Jul 2022
- Cyprus since 26 Jul 2022
- Czechia since 26 Jul 2022
- Denmark since 26 Jul 2022
- Estonia since 26 Jul 2022
- Finland since 26 Jul 2022
- France since 26 Jul 2022
- Germany since 26 Jul 2022
- Greece since 26 Jul 2022
- Hungary since 26 Jul 2022
- Iceland since 26 Jul 2022
- Ireland since 26 Jul 2022
- Italy since 26 Jul 2022
- Latvia since 26 Jul 2022
- Liechtenstein since 26 Jul 2022
- Lithuania since 26 Jul 2022
- Luxembourg since 26 Jul 2022
- Malta since 26 Jul 2022
- Netherlands since 26 Jul 2022
- Norway since 26 Jul 2022
- Poland since 26 Jul 2022
- Portugal since 26 Jul 2022
- Romania since 26 Jul 2022
- Slovakia since 26 Jul 2022
- Slovenia since 26 Jul 2022
- Spain since 26 Jul 2022
- Sweden since 26 Jul 2022
- Türkiye since 26 Jul 2022
Specification
- Device Name
- Hand Therapy
- Model / Reference
- 3110-23
- Primary DI / UDI-DI
- 05050996015767
- Basic UDI-DI
- 50554741B17H
- EMDN Code
- Y060612 Wrist-hand orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000008558
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Promedics Orthopaedics Limited
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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