N61H04
by Leboo Healthcare Products Limited
Ref N61H04Model Isolation Gown Pack, Lab Coat Pack, Doctor Set Pack and other customized specifications
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 | Number697442484L19QS | Date8 Aug 2024 | 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- Withdrawn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
- Model / Reference
- Isolation Gown Pack, Lab Coat Pack, Doctor Set Pack and other customized specifications, N61H04
- Primary DI / UDI-DI
- 06974424842819, 06974424849023, 06974424848149
- Basic UDI-DI
- 697442484L19QS
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000008521
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Leboo Healthcare Products Limited
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