MANU-HiT POLLEX CLASSIC
by Sporlastic GmbH & Co. KG 2 variants
Ref 07640
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 | Number04029925Y060613V9 | Date16 Oct 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- Withdrawn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
- Mobilas
- Model / Reference
- 07640
- Primary DI / UDI-DI
- 04029925013892, 04029925013991, 04029925013960, 04029925250983, 04029925251058, 04029925251041, 04029925250990, 04029925013953, 04029925013915, 04029925251065, 04029925013939, 04029925251034, 04029925014028, 04029925013922, 04029925014035, 04029925014066, 04029925013977, 04029925014073, 04029925014011, 04029925250976, 04029925013908, 04029925251003, 04029925013946, 04029925251027, 04029925251010, 04029925013984, 04029925014042, 04029925014080, 04029925014004
- Basic UDI-DI
- 04029925Y060613V9
- EMDN Code
- Y060613 Wrist-hand-fingers orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006346
Other devices from SPORLASTIC GMBH & Co.KG
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