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Sterile syringes for single use (with needle)
EUDAMEDClass IIa (EU MDR)
Ref 8001Model 1ml
Identity
- Device Name
- Sterile syringes for single use (with needle) EUDAMED
- Model / Reference
- 1ml EUDAMED8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958692180019 EUDAMED
- Basic UDI-DI
- B-06958692180019 EUDAMED
- EMDN Code
- A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile syringes for single use (with needle) by Changzhou Yuandong Medical Equipments Co., Ltd. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06958692180019 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Yuandong Medical Equipments Co., Ltd.
- EUDAMED SRN
- CN-MF-000019968
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED b7399ce3-0e2f-47f0-ad36-fbbf359c20df 61 fields · synced Oct 6, 2026