SIMPLE OA Knee sleeve X1
by Simple Medical (Shenzhen) Limited EUDAMED
Active
Ref 11005-XXLModel 11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL),11007&11011&11014&11059,11005&11006(S/M/L/XL/XXL),11017 (S/L)),
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697124454KneeOrthosesED | Date8 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- 11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL), 11007&11011&11014&11059, 11005&11006(S/M/L/XL/XXL), 11017 (S/L)), 11005-XXL
- Primary DI / UDI-DI
- 06971244540093
- Basic UDI-DI
- 697124454KneeOrthosesED
- Direct Marketing DI
- 06971244540093
- EMDN Code
- Y061209 Knee orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000013198
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Simple Medical (Shenzhen) Limited
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