← Back to catalogue
Cys
EUDAMEDClass IIa (EU MDR)
Ref F0080M/CBI-M100 8.0mL/hModel CBI-M60 2.0mL/h CBI-M60 5.0mL/h CBI-M60 10.0mL/h CBI-M100 2.0mL/h CBI-M100 3.0mL/h CBI-M100 4.0mL/h CBI-M100 5.0mL/h CBI-M100 8.0mL/h CBI-M100 13.0mL/h etc
Identity
- Trade Name
- CYS EUDAMED
- Device Name
- Disposable Infusion Pump EUDAMED
- Model / Reference
- CBI-M60 2.0mL/h CBI-M60 5.0mL/h CBI-M60 10.0mL/h CBI-M100 2.0mL/h CBI-M100 3.0mL/h CBI-M100 4.0mL/h CBI-M100 5.0mL/h CBI-M100 8.0mL/h CBI-M100 13.0mL/h etc EUDAMEDF0080M/CBI-M100 8.0mL/h EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956862090250 EUDAMED
- Basic UDI-DI
- 69568620CBI5Q EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Cys by Changzhou Medical Bioengineering Co., 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 | 69568620CBI5Q | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Medical Bioengineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026604
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 610d3cc3-33bf-4783-92bd-798cfe37f0c2 61 fields · synced Jun 17, 2026