Prefilled syringe with purified water or glycerin solution
by Well Lead Medical Co., Ltd. 3 variants
Ref F02C021020Model Prefilled syringes with 5% Glycerin solution 5ml; Prefilled syringes with 5% Glycerin solution 10ml
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 | Number69449327FF02C00EG 06944932787506 | Date28 Feb 2023 | 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- Withdrawn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
- Model / Reference
- Prefilled syringes with 5% Glycerin solution 5ml, Prefilled syringes with 5% Glycerin solution 10ml, F02C021020
- Primary DI / UDI-DI
- 06944932787506
- Basic UDI-DI
- 69449327FF02C00EG
- EMDN Code
- A02010799 Prefilled syringes - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000006728
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Well Lead 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