Shoulder Immobilizer
by e-life International Co., Ltd. 8 variants
Ref MARFM05 (S/UNI/RB), MARAB01 (XL/UNI/BK), MARAB01 (L/UNI/BK), MARFM05 (M/UNI/RB), MARAB01 (2XL/UNI/BK), MARAB01 (S/UNI/BK), MAR0001 (XS/UNI/RB), MARFM07 (Universal/UNI/BG), MARAB01 (M/UNI/BK), MARAB01 (4XL/UNI/BK), MARFM05 (XL/UNI/RB)Model Arm Sling Series
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 | Number471230298ARQE | 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- Withdrawn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
- Trade Name
- Shoulder ImmobilizerShoulder Immobilizer with Abduction
- Device Name
- Arm immobilization sling and shoulder strap orthosis
- Model / Reference
- Arm Sling Series, MARFM05 (S/UNI/RB), MARAB01 (XL/UNI/BK), MARAB01 (L/UNI/BK), MARFM05 (M/UNI/RB), MARAB01 (2XL/UNI/BK), MARAB01 (S/UNI/BK), MAR0001 (XS/UNI/RB), MARFM07 (Universal/UNI/BG), MARAB01 (M/UNI/BK), MARAB01 (4XL/UNI/BK), MARFM05 (XL/UNI/RB)
- Primary DI / UDI-DI
- 04712302986567, 04712302986314, 04712302986307, 04712302986574, 04710374236061, 04712302986284, 04710374236054, 04712302986185, 04712302986291, 04710374236085, 04712302986598
- Basic UDI-DI
- 471230298ARQE
- EMDN Code
- Y060621 Shoulder 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