active MED
by PS Product Services GmbH 12 variants
Ref SP0123
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 | Number4050235PS0005BJ | Date7 Dec 2021 | 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- Withdrawn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
- Neopren-Bandagen
- Model / Reference
- SP0123
- Primary DI / UDI-DI
- 04050235001996, 04050235001972, 04050235002009, 04050235002030, 04050235002047, 04050235001989, 04050235002016
- Basic UDI-DI
- 4050235PS0005BJ
- Direct Marketing DI
- 04050235001996040502350019720405023500200904050235002030040502350020470405023500198904050235002016
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.)
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- DE-MF-000005290
Other devices from PS Product Services 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