Patient securement
by GRI Medical & Electronic Technology Co., Ltd. 7 variants
Ref 50-435, 50-KB2010, 50-KB1010, LM50-435, 50-583, 50-434, PSAB100N-EU, LM50-434, 50-KB1030, LM50-500, 50-595, 50-602, 50-582
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 | Number69319181F050KY | Date2 Sep 2022 | 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- Withdrawn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
- Patient securement
- Model / Reference
- 50-435, 50-KB2010, 50-KB1010, LM50-435, 50-583, 50-434, PSAB100N-EU, LM50-434, 50-KB1030, LM50-500, 50-595, 50-602, 50-582
- Primary DI / UDI-DI
- 16931918196091, 16931918194752, 16931918139999, 16931918125312, 16931918183688, 16931918142050, 16931918147123, 16931918159362, 16931918134321, 16931918159218, 16931918192482, 16931918155449, 16931918192611
- Basic UDI-DI
- 69319181F050KY
- Unit of Use DI
- 06931918125315, 06931918142053, 06931918159365, 06931918159211
- EMDN Code
- Z12011285 Patient positioning instruments - consumables
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000004203
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from GRI Medical & Electronic Technology Co., Ltd.
See all devices from GRI Medical & Electronic Technology 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