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A.V. fistula needle sets for single use Revolving wing 1.6mm(16G) Blue water st…
EUDAMEDClass IIa (EU MDR)
Ref A16RModel Model:Fixed wing，Revolving wing Specifications：2.1mm(14G)，1.8mm(15G)，1.6mm(16G)，1.4mm(17G)，1.2mm(18G)
Identity
- Trade Name
- A.V. fistula needle sets for single use Revolving wing 1.6mm(16G) Blue water stop clip EUDAMED
- Device Name
- A.V. fistula needle sets for single use EUDAMED
- Model / Reference
- Model:Fixed wing，Revolving wing Specifications：2.1mm(14G)，1.8mm(15G)，1.6mm(16G)，1.4mm(17G)，1.2mm(18G) EUDAMEDA16R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756717488 EUDAMED
- Basic UDI-DI
- 69207567DJMCCZ0001W8 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
A.V. fistula needle sets for single use Revolving wing 1.6mm(16G) Blue water st… by Jiangxi Hongda Medical Equipment Group 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 | 69207567DJMCCZ0001W8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d3c06d14-2344-47cc-a03a-4a56343dc666 61 fields · synced Jun 19, 2026