Identity
- Trade Name
- ACCU-PRO Pressure Infusion Bag, 1000ml EUDAMED
- Device Name
- ACCU-PRO Pressure Infusion Bags EUDAMED
- Model / Reference
- APPI01000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 25060179631824 EUDAMED
- Basic UDI-DI
- 50560945APPIMU EUDAMED
- Unit of Use DI
- 15060179631827 EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ACCU-PRO Pressure Infusion Bag, 1000ml by PROACT Medical Ltd. — Class I — 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 | 50560945APPIMU | Class I | Active |
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Manufacturer
- Manufacturer
- PROACT Medical Ltd.
- EUDAMED SRN
- GB-MF-000006294
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 363f1ba9-ba97-4538-8f6f-7d32b835dc3b 61 fields · synced Jul 24, 2026