Sterile Hypodermic Needles for Single Use
by Changzhou Shuangma Medical Devices Co., Ltd 6 variants
Ref 1207Model 0.4×15RWLB,0.45×15RWLB,0.5×20RWLB,0.5×36RWLB,0.55×20RWLB,0.6×25TWLB,0.7×30TWLB,0.8×36TWLB,0.9×36TWLB,1.1×30TWLB,1.2×30TWLB,30G×1/2(0.3×12.7mm),21G×1 1/2,23G×1,19G×1 1/2(1.1×32mm),22G×1 1/4(0.7×32mm),18GX1 1/2
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 | Number69451447004ZSZ8M 06945144712072 | Date28 May 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- Withdrawn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
- Model / Reference
- 0.4×15RWLB, 0.45×15RWLB, 0.5×20RWLB, 0.5×36RWLB, 0.55×20RWLB, 0.6×25TWLB, 0.7×30TWLB, 0.8×36TWLB, 0.9×36TWLB, 1.1×30TWLB, 1.2×30TWLB, 30G×1/2(0.3×12.7mm), 21G×1 1/2, 23G×1, 19G×1 1/2(1.1×32mm), 22G×1 1/4(0.7×32mm), 18GX1 1/2, 1207
- Primary DI / UDI-DI
- 06945144712072
- Basic UDI-DI
- 69451447004ZSZ8M
- EMDN Code
- A0101010102 Hypodermic syringe needles, w/o safety systems
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009732
- Authorised representative
- Llins Service & Consulting GmbH DE-AR-000009077
Other devices from Changzhou Shuangma Medical Devices Co., Ltd
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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