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Infusion Supervision System
EUDAMEDClass IIb (EU MDR)
Ref CODAN 400 DModel BioFusion DS100
Identity
- Trade Name
- Infusion Supervision System EUDAMED
- Device Name
- Infusion Supervision System EUDAMED
- Model / Reference
- BioFusion DS100 EUDAMEDCODAN 400 D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562301964 EUDAMED
- Basic UDI-DI
- 69325623300064R EUDAMED
- EMDN Code
- Z12030306 INFUSION AND SYRINGE PUMP CONTROL SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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 Supervision System by Guangdong Biolight Meditech Co., 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 | 69325623300064R | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8b096cfd-529f-4f83-ad8c-6fc9b3f946b2 61 fields · synced Jun 18, 2026