Identity
- Trade Name
- Infusion sets for single use EUDAMED
- Device Name
- Infusion Sets for Single Use EUDAMED
- Model / Reference
- B1 EUDAMEDB101L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756700305 EUDAMED
- Basic UDI-DI
- 69207567GSYQ000199 EUDAMED
- EMDN Code
- A03010199 INFUSION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion sets for single use by Jiangxi Hongda Medical Equipment Group Ltd. — Class IIb — 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 | 69207567GSYQ000199 | Class IIb | 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 2c32d4da-2e24-4090-b7d4-efb7685e1c8e 61 fields · synced Jun 19, 2026