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Disposable Automatically Retractable Safety Syringe ( with exchangable needle )
EUDAMEDClass IIa (EU MDR)
Ref SSDN005Model 0.5ml 1ml 3ml 5ml 10ml 20mlRef SSDN10Ref SSDN05Ref SSDN03
Identity
- Trade Name
- Disposable Automatically Retractable Safety Syringe ( with exchangable needle ) EUDAMED
- Device Name
- Disposable Safety Syringe(with detachable needle) EUDAMED
- Model / Reference
- 0.5ml 1ml 3ml 5ml 10ml 20ml EUDAMEDSSDN005 EUDAMEDSSDN10 EUDAMEDSSDN05 EUDAMEDSSDN03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971603585550 EUDAMED06971603585673 EUDAMED06971603585642 EUDAMED06971603585611 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 Retractable 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 (4)
- EUDAMED 108caae5-b175-4750-8438-cd1ee2bb618e 61 fields · synced Oct 6, 2026
- EUDAMED 16bf63d3-87be-46b9-8d6b-f5df5d9897bc 61 fields · synced May 11, 2026
- EUDAMED a7cbf17f-7c8b-4c29-93cb-77d61d41b100 61 fields · synced May 17, 2026
- EUDAMED 2ae93e99-eb3a-484c-9279-34bc4ca09af4 61 fields · synced May 19, 2026