Identity
- Trade Name
- Disposable Irrigation Syringe EUDAMED
- Device Name
- Disposable Irrigation Syringes EUDAMED
- Model / Reference
- 60ml EUDAMED60B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971603585048 EUDAMED
- Basic UDI-DI
- 697160358WDISP8 EUDAMED
- EMDN Code
- A02010203 INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Irrigation Syringe by Shantou Wealy Medical Instrument Co., Ltd. — Class I — 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 | 697160358WDISP8 | Class I | 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 1f2909b9-c051-474c-9d2b-e74164a3a6e6 61 fields · synced Oct 6, 2026