FinnComfort
by Waldi Schuhfabrik GmbH 1,000+ variants
Ref 01197-545037
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- Withdrawn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
- 01197-545037
- Primary DI / UDI-DI
- 00888281939482, 00888281939475, 00888281939420, 00888281939369, 00888281939413, 00888281939390, 00888281939383, 00888281939468, 00888281939437, 00888281939406, 00888281939376, 00888281939444, 00888281939451
- Basic UDI-DI
- 4030457-FinnCo-001-MN
- Direct Marketing DI
- 00888281939482008882819394750088828193942000888281939369008882819394130088828193939000888281939383008882819394680088828193943700888281939406008882819393760088828193944400888281939451
- 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