Rollator
by Babylove Industrial Co., Ltd. 12 variants
Ref LETT900P / S4-MOON
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 | Number471988903R900PFP 04719889030034 | Date5 Sep 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- Withdrawn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
- Rollator
- Model / Reference
- LETT900P / S4-MOON
- Primary DI / UDI-DI
- 04719889030034
- Basic UDI-DI
- 471988903R900PFP
- Direct Marketing DI
- 04719889030034
- EMDN Code
- Y120609 Walking frames with chair, 4 wheels
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- TW-MF-000019120
- Authorised representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Other devices from Babylove Industrial 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