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Disposable Automatically Rereactable Safety Syringe ( with exchangable needle )
EUDAMEDClass IIa (EU MDR)
Ref SSDN01Model 0.5ml 1ml 3ml 5ml 10ml 20ml
Identity
- Trade Name
- Disposable Automatically Rereactable Safety Syringe ( with exchangable needle ) EUDAMED
- Device Name
- Disposable Safety Syringe(with detachable needle) EUDAMED
- Model / Reference
- 0.5ml 1ml 3ml 5ml 10ml 20ml EUDAMEDSSDN01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971603585581 EUDAMED
- Basic UDI-DI
- 697160358WDSSW/D7G EUDAMED
- EMDN Code
- A02010205 INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Disposable Automatically Rereactable Safety Syringe ( with exchangable needle ) by Shantou Wealy Medical Instrument Co., Ltd. — Class IIa — MDR — listed in…
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 | 697160358WDSSW/D7G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shantou Wealy Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020619
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9c479df4-d688-4093-8e6a-a166892c55db 61 fields · synced Oct 6, 2026