FinnComfort
by Waldi Schuhfabrik GmbH 1,000+ variants
Ref 01575-422124
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
FinnComfort is a medical device designed for comfortable orthotics and shoe fittings, offering improved patient outcomes and enhanced healthcare experiences. With its sterile status confirmed as 0, this device is perfect for high-volume applications where precision is key.
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- Withdrawn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
- 01575-422124
- Primary DI / UDI-DI
- 04030457496640, 04030457496657, 04030457467312, 04030457467374, 04030457467336, 04030457496688, 04030457467350, 04030457467343, 04030457496671, 04030457467329, 04030457496664, 04030457467367, 04030457467305
- Basic UDI-DI
- 4030457-FinnCo-001-MN
- Direct Marketing DI
- 04030457496640040304574966570403045746731204030457467374040304574673360403045749668804030457467350040304574673430403045749667104030457467329040304574966640403045746736704030457467305
- 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