Ankle, Heel & Foot Orthosis Brace
by Fortune Company Limited 7 variants
Ref H04-S2Model A01-S2,A01-L2,A02-SM,A02-MD,A02-LG,A02-XL,A03b-S2,A03b-L2,A04-UN,A06-UN,A08-UN,A08-SM,A08-MD,A08-LG,A09-UN,A09-S2,A09-L2,A10-UN,A11-SM-LT,A11-MD-LT,A11-LG-LT,A11-XL-LT,A11-SM-RT,A11-MD-RT,A11-LG-RT,A11-XL-RT, etc.
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 | Number698005810AHFOBC3 06980058103974 | Date13 Jul 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- Withdrawn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
- Device Name
- Ankle, Heel & Foot Orthosis Brace
- Model / Reference
- A01-S2, A01-L2, A02-SM, A02-MD, A02-LG, A02-XL, A03b-S2, A03b-L2, A04-UN, A06-UN, A08-UN, A08-SM, A08-MD, A08-LG, A09-UN, A09-S2, A09-L2, A10-UN, A11-SM-LT, A11-MD-LT, A11-LG-LT, A11-XL-LT, A11-SM-RT, A11-MD-RT, A11-LG-RT, A11-XL-RT, etc., H04-S2
- Primary DI / UDI-DI
- 06980058103974
- Basic UDI-DI
- 698005810AHFOBC3
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000023028
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Fortune Company Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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