Helsinki
Ref 1113
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 | Number4009706M03049903PQ | Date8 Jun 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- Withdrawn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
- Lymph drainage and compression garments
- Model / Reference
- 1113
- Primary DI / UDI-DI
- 04009706406068, 04058509479519, 04009706405788, 04009706406044, 04058509479502, 04058509479526, 04058509479533, 04009706405795, 04009706406051, 04058509479496
- Basic UDI-DI
- 4009706M03049903PQ
- Direct Marketing DI
- 04009706406068040585094795190400970640578804009706406044040585094795020405850947952604058509479533040097064057950400970640605104058509479496
- EMDN Code
- M030499 Elastic bandages, support and compression - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- DE-MF-000012631
Other devices from Anita Dr. Helbig 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