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Infusion Supervision System
EUDAMEDClass IIb (EU MDR)
Ref BioFusion DS100T ProModel BioFusion DS100Ref BioFusion DS100TRef CODAN 200 D
Identity
- Trade Name
- Infusion Supervision System EUDAMED
- Device Name
- Infusion Supervision System EUDAMED
- Model / Reference
- BioFusion DS100 EUDAMEDBioFusion DS100T Pro EUDAMEDBioFusion DS100T EUDAMEDCODAN 200 D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562301216 EUDAMED06932562301186 EUDAMED06932562301193 EUDAMED06932562301957 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
- Poland EUDAMEDGermany 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 (4)
- EUDAMED 02a27396-6ae3-4855-a105-5188b3928b82 61 fields · synced Sep 17, 2026
- EUDAMED 03c299bb-2078-41c6-97a0-866a13bf61d1 61 fields · synced May 17, 2026
- EUDAMED 0e5c608d-0ecb-4beb-a89e-eba9dc69f97c 61 fields · synced May 18, 2026
- EUDAMED 4eeed6fc-da35-4437-a714-f51e32ee4f71 61 fields · synced May 18, 2026