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Single-use lightproof infusion set 0.8mm
EUDAMEDClass IIa (EU MDR)
Ref BL302Model Model:P-P Needle size:0.45mm,0.5mm,0.55mm,0.6mm,0.7mm,0.8mm,0.9mm,1.2mm
Identity
- Trade Name
- Single-use lightproof infusion set 0.8mm EUDAMED
- Device Name
- Single-use lightproof infusion set EUDAMED
- Model / Reference
- Model:P-P Needle size:0.45mm,0.5mm,0.55mm,0.6mm,0.7mm,0.8mm,0.9mm,1.2mm EUDAMEDBL302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756706000 EUDAMED
- Basic UDI-DI
- 69207567BGSYQ0001L4 EUDAMED
- EMDN Code
- A03010199 INFUSION CONTROLLERS - OTHER 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Single-use lightproof infusion set 0.8mm by Jiangxi Hongda Medical Equipment Group 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 | 69207567BGSYQ0001L4 | 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 c0a31e03-e056-4613-aca0-6b02f0259526 61 fields · synced Oct 5, 2026