Single-use Injection Therapy Needle Catheter
by Leo Medical Co., Ltd. 61 variants
Ref L211816256Model L212324214
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69411123L21TE 06941112312060 | Date17 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Single-use Injection Therapy Needle Catheter
- Model / Reference
- L212324214, L211816256
- Primary DI / UDI-DI
- 06941112312060
- Basic UDI-DI
- 69411123L21TE
- Direct Marketing DI
- 06941112312060
- EMDN Code
- G03020101 Digestive endoscopy, single-lumen needles
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000012017
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Leo Medical Co., Ltd.
Properties
Other properties (12)
- 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