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Disposable Safety Syringe (auto-disable)
EUDAMEDClass IIa (EU MDR)
Ref SSAD01Model 0.5ml 1ml 3ml 5ml 10mlRef SSAD20Ref SSAD005Ref SSAD03Ref SSAD05
Identity
- Trade Name
- Disposable Safety Syringe (auto-disable) EUDAMED
- Device Name
- Disposable Safety Syringe (auto-disable) EUDAMED
- Model / Reference
- 0.5ml 1ml 3ml 5ml 10ml EUDAMEDSSAD01 EUDAMEDSSAD20 EUDAMEDSSAD005 EUDAMEDSSAD03 EUDAMEDSSAD05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971603585376 EUDAMED06971603585499 EUDAMED06971603585345 EUDAMED06971603585406 EUDAMED06971603585437 EUDAMED
- Basic UDI-DI
- 697160358WDSSADTG 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 Safety Syringe (auto-disable) by Shantou Wealy Medical Instrument 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 | 697160358WDSSADTG | 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 (5)
- EUDAMED f8a411d7-3c22-47c9-80d6-89d48ac6bc67 61 fields · synced Oct 6, 2026
- EUDAMED a7da56e7-6fdc-4d51-9c68-9ae3397ec66a 61 fields · synced May 18, 2026
- EUDAMED 95419101-14f7-482e-bee9-b9b4a50ed07c 61 fields · synced May 18, 2026
- EUDAMED 6a4af0ae-ef84-4351-b10d-43a21eb8b388 61 fields · synced May 18, 2026
- EUDAMED 33f98aeb-080c-4427-9563-1cb6c264e501 61 fields · synced May 18, 2026