Identity
- Trade Name
- BIOSAFE EUDAMED
- Device Name
- Disposable Sterile Syringes with Needle EUDAMED
- Model / Reference
- TD-SN-F EUDAMEDTD-SN-F-50ml-1.2mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945632020153 EUDAMED
- Basic UDI-DI
- 69456320SYN006US 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
- Romania 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Biosafe by Changzhou Tongda Medical Appliance Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69456320SYN006US | 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 (1)
- EUDAMED 52e97523-3f8f-4bba-8f3e-26b03a6aaf8f 61 fields · synced Jun 20, 2026