Sheet with Top Cover
Ref 71601Model 1/10”
Sheet with Top Cover (71601) is a Class I device made by Brownmed, Inc., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 081261SSSTCCW), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081261SSSTCCW 00082161716013 | Date1 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 081261SSSTCCW
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- Withdrawn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
- Soft Stride™ Sheet with Top Cover
- Model / reference
- 1/10”, 71601
- Primary DI / UDI-DI
- 00082161716013
- Basic UDI-DI
- 081261SSSTCCW
- EMDN code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008271
- Authorised representative
- AR Experts B.V. NL-AR-000023989
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