Patient Positioning System
by Klarity Medical & Equipment(GZ) Co., Ltd. 172 variants
Ref R624-SCF2-2Model Many
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number692082412141CM 06920824104811 | Date1 Aug 2025 | 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- Withdrawn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 Positioning System
- Model / reference
- Many, R624-SCF2-2
- Primary DI / UDI-DI
- 06920824104811
- Basic UDI-DI
- 692082412141CM
- EMDN code
- Z12011280 Patient positioning instruments - hardware accessories
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000002229
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No