Identity
- Trade Name
- Sterile Intravenous Needles for Single Use EUDAMED
- Device Name
- Sterile Intravenous Needles for Single Use EUDAMED
- Model / Reference
- 19G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957933268097 EUDAMED
- Basic UDI-DI
- B-06957933268097 EUDAMED
- EMDN Code
- A01010202 BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Intravenous Needles for Single Use by Changzhou Chuangjia Medical Appliance Co., Ltd. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06957933268097 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Chuangjia Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000026071
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b64badcd-cfaa-423a-8427-35f8cd258f83 61 fields · synced Oct 6, 2026