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Softmed
EUDAMEDClass IIa (EU MDR)
Ref TD-TSN-A-1ml-0.5mmModel TD-TSN-ARef TD-AD-A-5ml-0.6mmModel TD-AD-ARef TD-AD-B-10ml-0.7mmModel TD-AD-BRef TD-INS-B-1ml-U100-0.3mmModel TD-INS-BRef TD-OS-1mlModel TD-OS
Identity
- Trade Name
- SOFTMED EUDAMED
- Device Name
- Disposable Tuberculin syringes with needle EUDAMEDDisposable Auto-destroy Syringes with Needle EUDAMEDDisposable Insulin Syringes EUDAMEDOral syringes EUDAMED
- Model / Reference
- TD-TSN-A EUDAMEDTD-TSN-A-1ml-0.5mm EUDAMEDTD-AD-A EUDAMEDTD-AD-A-5ml-0.6mm EUDAMEDTD-AD-B EUDAMEDTD-AD-B-10ml-0.7mm EUDAMEDTD-INS-B EUDAMEDTD-INS-B-1ml-U100-0.3mm EUDAMEDTD-OS EUDAMEDTD-OS-1ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945632020672 EUDAMED06945632020221 EUDAMED06945632020238 EUDAMED06945632020191 EUDAMED06945632020405 EUDAMED
- Basic UDI-DI
- 69456320TSN001ST EUDAMED69456320AD001EG EUDAMED69456320AD002EJ EUDAMED69456320INS002MS EUDAMED69456320OS001NK EUDAMED
- EMDN Code
- A020109 TUBERCULIN SYRINGES, SINGLE-USE EUDAMEDA020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMEDA02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMEDA020108 ENTERAL FEEDING SYRINGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Softmed 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 | 69456320TSN001ST | 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 (5)
- EUDAMED 4d6894a4-7958-40a1-8aa3-5a3aafc5fc61 61 fields · synced Oct 7, 2026
- EUDAMED 1e5d2718-c21e-4b05-9cde-2b3079d4874e 61 fields · synced May 17, 2026
- EUDAMED 45bb0101-e3ce-4668-8b9f-1e0432220387 61 fields · synced May 17, 2026
- EUDAMED 3a880739-44b8-42c7-8cdc-ec6cf169bd00 61 fields · synced May 17, 2026
- EUDAMED 1a3bb824-fcdf-4242-afff-e37798aa8a14 61 fields · synced May 18, 2026