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Disposable sterile syringes (with needle)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref TD-SN-A-5ml-0.8mmModel TD-SN-A
Identity
- Device Name
- Disposable sterile syringes (with needle) EUDAMED
- Model / Reference
- TD-SN-A EUDAMEDTD-SN-A-5ml-0.8mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945632011011 EUDAMED
- Basic UDI-DI
- 69456320SYN001UG 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
- Greece 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable sterile syringes (with needle) by Changzhou Tongda Medical Appliance 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 | K232950 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69456320SYN001UG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Tongda Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000027398
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED ac4cc806-ef3c-44fe-8d63-b3e0b98879df 61 fields · synced Jun 19, 2026
- FDA 510(k) K232950 1 fields · synced May 18, 2026