Identity
- Device Name
- Disposable Syringes with Needles EUDAMED
- Model / Reference
- 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975266040036 EUDAMED
- Basic UDI-DI
- B-06975266040036 EUDAMED
- EMDN Code
- A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Syringes with Needles by Shandong Qinkai Medical Industry Co.Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211482 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06975266040036 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Qinkai Medical Industry Co.Ltd
- EUDAMED SRN
- CN-MF-000030489
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 59e01915-a281-44f2-9ec5-8aa0cf65e3b1 61 fields · synced Jun 19, 2026
- FDA 510(k) K211482 1 fields · synced May 18, 2026