Knee Immobilizer
by e-life International Co., Ltd. 28 variants
Ref MKNFM81 (S/UNI/BG/12), MKNFM81 (XL/UNI/BG/22), MKNP881 (Pediatric/UNI/RB), MKNFM81 (Universal/UNI/BK/20), MKNFM81 (2XL/UNI/GY/20), MKNFM81 (L/UNI/BG/24), MKNFM81 (M/UNI/BG/12), MKNFM81 (S/UNI/BG/16), MKNFM81 (M/UNI/BG/24), MKNFM81 (S/UNI/GY/20), MKNFM81 (2XL/UNI/BG/20), MKNFM81 (M/UNI/BG/14), MKNFM81 (S/UNI/BK/20), MKNFM81 (S/UNI/BG/14), MKNFM81 (S/UNI/GY/22), MKNFM81 (XL/UNI/BG/14), MKNFM81 (M/UNI/BG/16), MKNFM81 (XL/UNI/BK/20), MKNFM81 (L/UNI/BK/20), MKNFM81 (M/UNI/BG/18), MKNFM81 (XL/UNI/BG/20), MKNFM81 (S/UNI/BG/24), MKNFM81 (XL/UNI/GY/22), MKNFM81 (M/UNI/GY/20), MKNFM81 (XL/UNI/BG/18), MKNFM81 (XL/UNI/BG/24), MKNFM81 (2XL/UNI/BG/24), MKNFM81 (XL/UNI/GY/16), MKNFM81 (2XL/UNI/BK/20), MKNFM81 (XL/UNI/GY/20), MKNFM81 (2XL/UNI/BG/16), MKNFM81 (Universal/UNI/GY/20)Model Knee Brace Series
Active
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 | Number471230298KNR4 | Date30 Apr 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- Withdrawn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
- Knee orthosis and tubular support bandage
- Model / Reference
- Knee Brace Series, MKNFM81 (S/UNI/BG/12), MKNFM81 (XL/UNI/BG/22), MKNP881 (Pediatric/UNI/RB), MKNFM81 (Universal/UNI/BK/20), MKNFM81 (2XL/UNI/GY/20), MKNFM81 (L/UNI/BG/24), MKNFM81 (M/UNI/BG/12), MKNFM81 (S/UNI/BG/16), MKNFM81 (M/UNI/BG/24), MKNFM81 (S/UNI/GY/20), MKNFM81 (2XL/UNI/BG/20), MKNFM81 (M/UNI/BG/14), MKNFM81 (S/UNI/BK/20), MKNFM81 (S/UNI/BG/14), MKNFM81 (S/UNI/GY/22), MKNFM81 (XL/UNI/BG/14), MKNFM81 (M/UNI/BG/16), MKNFM81 (XL/UNI/BK/20), MKNFM81 (L/UNI/BK/20), MKNFM81 (M/UNI/BG/18), MKNFM81 (XL/UNI/BG/20), MKNFM81 (S/UNI/BG/24), MKNFM81 (XL/UNI/GY/22), MKNFM81 (M/UNI/GY/20), MKNFM81 (XL/UNI/BG/18), MKNFM81 (XL/UNI/BG/24), MKNFM81 (2XL/UNI/BG/24), MKNFM81 (XL/UNI/GY/16), MKNFM81 (2XL/UNI/BK/20), MKNFM81 (XL/UNI/GY/20), MKNFM81 (2XL/UNI/BG/16), MKNFM81 (Universal/UNI/GY/20)
- Primary DI / UDI-DI
- 04712302989834, 04712302989094, 04712302988875, 04710374238584, 04719894924069, 04712302981463, 04712302989841, 04712302989797, 04712302981456, 04719894924045, 04712302980749, 04710374239772, 04710374239734, 04710374239703, 04710374239758, 04710374239932, 04712302989803, 04710374239963, 04710374239888, 04712302989766, 04712302980732, 04712302981449, 04710374239987, 04710374239819, 04712302989780, 04712302981470, 04712302980756, 04710374239956, 04719894924236, 04719894924052, 04712302985669, 04719894924229
- Basic UDI-DI
- 471230298KNR4
- EMDN Code
- Y061209 Knee orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000009901
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from e-life International Co., 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