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reusable pressure infuser
EUDAMEDClass I (EU MDR)
Ref RU500AGSFLEXModel 100ml, 200ml, 300ml, 500ml, 600ml, 700ml, 800ml, 1000ml, 1500ml, 2000ml, 3000ml, 4000ml, 5000mlRef RU1000AGSFLEX
Identity
- Trade Name
- reusable pressure infuser EUDAMED
- Device Name
- Pressure Infusion Cuff EUDAMED
- Model / Reference
- 100ml, 200ml, 300ml, 500ml, 600ml, 700ml, 800ml, 1000ml, 1500ml, 2000ml, 3000ml, 4000ml, 5000ml EUDAMEDRU500AGSFLEX EUDAMEDRU1000AGSFLEX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919462477 EUDAMED06971919460459 EUDAMED
- Basic UDI-DI
- 697191946PICVH EUDAMED
- EMDN Code
- A088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
reusable pressure infuser by Ningbo Albert Novosino Co., 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 | 697191946PICVH | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 858b4db3-52bb-4501-a4f0-0e511ccef6ec 61 fields · synced Aug 3, 2026
- EUDAMED 67b6d0a8-4f5b-4d14-837c-e1d8f7e96c48 61 fields · synced May 18, 2026