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Sterile Hypodermic Syringes for Single Use
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 01.02.01.0594Ref 01.02.01.0534
Identity
- Trade Name
- Sterile Hypodermic Syringes for Single Use EUDAMEDSterile Hypodermic Syringes for Single Use Without Needle EUDAMED
- Device Name
- Sterile Hypodermic Syringes for Single Use EUDAMEDSterile Hypodermic Syringes for Single Use Without Needle EUDAMED
- Model / Reference
- 01.02.01.0594 EUDAMED01.02.01.0534 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932992171731 EUDAMED06932992171748 EUDAMED
- Basic UDI-DI
- 69329921YCXWJZSQ0000004TG EUDAMED69329921SHSFSUWN00000074S EUDAMED
- EMDN Code
- A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMEDA020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Hypodermic Syringes for Single Use by Shandong Weigao Group Medical Polymer Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212207 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69329921YCXWJZSQ0000004TG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Weigao Group Medical Polymer Co., Ltd.
- EUDAMED SRN
- CN-MF-000011129
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (3)
- EUDAMED ab4b82a4-1ba3-48bc-a600-7cc5e05f42eb 61 fields · synced Jul 9, 2026
- EUDAMED 29a32f00-0287-4d5f-a87d-23c9f39f3d99 61 fields · synced May 18, 2026
- FDA 510(k) K212207 1 fields · synced May 18, 2026