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Disposable Infusion Pump
EUDAMEDClass IIa (EU MDR)
Ref CBI+PCA-M100 2.0ml/hModel CBI+PCA-M100 2.0mL/h CBI+PCA-M100 3.0mL/h CBI+PCA-M100 4.0mL/h CBI+PCA-M200 2.0mL/h CBI+PCA-M200 3.0mL/h CBI+PCA-M200 4.0mL/h CBI+PCA-M275 2.0mL/h CBI+PCA-M275 3.0mL/h CBI+PCA-M275 4.0mL/h CBI+PCA-M275 5.0mL/h etc
Identity
- Device Name
- Disposable Infusion Pump EUDAMED
- Model / Reference
- CBI+PCA-M100 2.0mL/h CBI+PCA-M100 3.0mL/h CBI+PCA-M100 4.0mL/h CBI+PCA-M200 2.0mL/h CBI+PCA-M200 3.0mL/h CBI+PCA-M200 4.0mL/h CBI+PCA-M275 2.0mL/h CBI+PCA-M275 3.0mL/h CBI+PCA-M275 4.0mL/h CBI+PCA-M275 5.0mL/h etc EUDAMEDCBI+PCA-M100 2.0ml/h EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956862090267 EUDAMED
- Basic UDI-DI
- 69568620PCA7C EUDAMED
- EMDN Code
- A05010101,A05010102 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Infusion Pump 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 | 69568620PCA7C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Medical Bioengineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026604
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED cf6bc159-f93a-4d86-a88a-be673a2613f2 61 fields · synced Jul 13, 2026