FinnComfort
by Waldi Schuhfabrik GmbH 1,000+ variants
Ref 02397-900158
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 | Number4030457-FinnCo-001-MN | Date8 May 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- Withdrawn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
- Model / Reference
- 02397-900158
- Primary DI / UDI-DI
- 04030457419199, 04030457419182, 04030457419236, 04030457419243, 04030457419151, 04030457419168, 04030457419229, 04030457419144, 04030457419212, 04030457419175, 04030457419250, 04030457419137, 04030457419205
- Basic UDI-DI
- 4030457-FinnCo-001-MN
- Direct Marketing DI
- 04030457419199040304574191820403045741923604030457419243040304574191510403045741916804030457419229040304574191440403045741921204030457419175040304574192500403045741913704030457419205
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000016907
Other devices from Waldi Schuhfabrik GmbH
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