FinnComfort
by Waldi Schuhfabrik GmbH 1,000+ variants
Ref 01197-055099
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- Withdrawn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
- 01197-055099
- Primary DI / UDI-DI
- 00888281551936, 00888281552018, 00888281551950, 00888281551974, 00888281551998, 00888281551943, 00888281551981, 00888281551967, 00888281551912, 00888281552001, 00888281552032
- Basic UDI-DI
- 4030457-FinnCo-001-MN
- Direct Marketing DI
- 0088828155193600888281552018008882815519500088828155197400888281551998008882815519430088828155198100888281551967008882815519120088828155200100888281552032
- 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